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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73184

119 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 25, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biomet 3i, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

119 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 119

Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants

Z-2406-2016
Recall number
Z-2406-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1152118

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 2 of 119

Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants

Z-2407-2016
Recall number
Z-2407-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1153081

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 3 of 119

Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) Item: IWTH564 Dental implants

Z-2408-2016
Recall number
Z-2408-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1150836

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 4 of 119

Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants

Z-2409-2016
Recall number
Z-2409-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1154709-5

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 5 of 119

Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants

Z-2410-2016
Recall number
Z-2410-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1154388-5

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 6 of 119

Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants

Z-2411-2016
Recall number
Z-2411-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1147381, 1153937, and 1153938

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 7 of 119

Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental implants

Z-2412-2016
Recall number
Z-2412-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1151936, 1151937, and 1151938

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 8 of 119

Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implants

Z-2413-2016
Recall number
Z-2413-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1148354 and 1155382

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 9 of 119

Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants

Z-2414-2016
Recall number
Z-2414-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1152085

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 10 of 119

Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants

Z-2415-2016
Recall number
Z-2415-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1154337 and 1154338

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 11 of 119

Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants

Z-2416-2016
Recall number
Z-2416-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1152487

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 12 of 119

Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants

Z-2417-2016
Recall number
Z-2417-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1155282 and 1155283

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 13 of 119

Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants

Z-2418-2016
Recall number
Z-2418-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1157768-CN, 1160929-CN, 1160930-CN, 1160931-CN, 987129-5, 996343-5, and 998147-5

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 14 of 119

Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental implants

Z-2419-2016
Recall number
Z-2419-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1154271-5

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 15 of 119

Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants

Z-2420-2016
Recall number
Z-2420-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1071150, 1071151, 1071152, and 1071190

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 16 of 119

Gold-Tite Square Uniscrew Item: UNISG Dental implants

Z-2421-2016
Recall number
Z-2421-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1152611 and 1153193

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 17 of 119

LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants

Z-2422-2016
Recall number
Z-2422-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1087614

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 18 of 119

LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants

Z-2423-2016
Recall number
Z-2423-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1087616

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 19 of 119

O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants

Z-2424-2016
Recall number
Z-2424-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1002024, 1014103, 1022623, 1030863, 1031271, 1051924, 1054014, 1057816, 1068294, 1069738, 1071756, 1078857, 1082342, 1095159, 1095387, 1129684, 1131304, 1141288, 1161312, 1168381, 1169242, 1169931, 1170162, 1173357, 987787, and 987884

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 20 of 119

O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants

Z-2425-2016
Recall number
Z-2425-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1014104, 1022991, 1033058, 1041417, 1052716, 1054542, 1060675, 1069646, 1088483, 1094776, 1106610, 1129686, 1141289, 1168523, 1168829, 1172024, and 996069.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 21 of 119

O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants

Z-2426-2016
Recall number
Z-2426-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot # 1068337, 1116902, and 997344

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 22 of 119

Locator Extended Range Males 4pk Dental implants

Z-2427-2016
Recall number
Z-2427-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: LAERM

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 23 of 119

Locator Extra Light Angled Replacement Males 4pk Dental implants

Z-2428-2016
Recall number
Z-2428-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: LELARM

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 24 of 119

Locator Extra Light Retention Males 4pk Dental implants

Z-2429-2016
Recall number
Z-2429-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item:LAELM

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 25 of 119

Locator Light Retention Replacement Males 4pk Dental implants

Z-2430-2016
Recall number
Z-2430-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item:LLRMS

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 26 of 119

Locator Replacement Housing Dental implants

Z-2431-2016
Recall number
Z-2431-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item:LOAH

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 27 of 119

Locator Replacement Housing Kit Dental implants

Z-2432-2016
Recall number
Z-2432-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item:LORHK

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 28 of 119

Locator Replacement Males 4pk Dental implants

Z-2433-2016
Recall number
Z-2433-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to these recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item:LARMS

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 29 of 119

Pick-Up Impression Coping Dental implants

Z-2434-2016
Recall number
Z-2434-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 (all products subject to thIs recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: MIC33

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 30 of 119

Preformance 15 degrees pre-angled post Dental implants

Z-2435-2016
Recall number
Z-2435-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: MPAPF34, MPAPF36, PAPF454, PAPF456, PAPF554, PAPF556 and PAPF666

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 31 of 119

Preformance Post Dental implants

Z-2436-2016
Recall number
Z-2436-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: MPFP34, MPFP36, PFP454, PFP456, WPFP554, WPFP556 and WPFP666.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 32 of 119

Preformance Temporary Cylinder Dental implants

Z-2437-2016
Recall number
Z-2437-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: MPFTC34, MPTC32, PFTC41, PFTC42, WPFTC51, WPFTC52, WPFTC61 and WPFTC62.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 33 of 119

Prep-tite Cap Dental implants

Z-2438-2016
Recall number
Z-2438-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: MPFTC34, MPTC32, PFTC41, PFTC42, WPFTC51, WPFTC52, WPFTC61 and WPFTC62.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 34 of 119

Prep-Tite Post Dental implants

Z-2439-2016
Recall number
Z-2439-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: APP42, WPP552 and WPP662.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 35 of 119

Provide Impression Coping Dental implants

Z-2440-2016
Recall number
Z-2440-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item:PIC484, PIC485, PIC654, PIC655, PIC484H, PIC485H and PIC654H.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 36 of 119

Provide Protection Cap Dental implants

Z-2441-2016
Recall number
Z-2441-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: PPC484, PPC485, PPC654 and PPC655.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 37 of 119

Quickbridge TM Cap Dental implants

Z-2442-2016
Recall number
Z-2442-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: QBCAP

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 38 of 119

Standard Abutment Dental implants

Z-2443-2016
Recall number
Z-2443-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: AB200, AB300, AB400, AB500 and AB700.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 39 of 119

Standard Abutment Pick -Up Coping Dental implants

Z-2444-2016
Recall number
Z-2444-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: SQIC7

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 40 of 119

Standard Abutment Temporary Screw Dental implants

Z-2445-2016
Recall number
Z-2445-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: TS250

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 41 of 119

Standard Abutment Transfer Coping Dental implants

Z-2446-2016
Recall number
Z-2446-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: SIC70

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 42 of 119

Temporary Healing Retention Cylinder Dental implants

Z-2447-2016
Recall number
Z-2447-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: THRC4 and THRC6.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 43 of 119

Temporary Hexed Cylinder Dental implants

Z-2448-2016
Recall number
Z-2448-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: MMTCS1, ITCS41, WTCS51 and WTCS61.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 44 of 119

Temporary Non-Hexed Cylinder Dental implants

Z-2449-2016
Recall number
Z-2449-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: ITCS42, WTCS52 and WTCS62.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 45 of 119

Titanium Hexed Uniscrew Dental implants

Z-2450-2016
Recall number
Z-2450-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: UNIHT

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 46 of 119

Titanium Square Uniscrew Dental implants

Z-2451-2016
Recall number
Z-2451-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: UNIST

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 47 of 119

Conical EP Healing Cap Dental implants

Z-2452-2016
Recall number
Z-2452-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: CS250, CS260 and CS270.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 48 of 119

Conical EP Pick-Up Coping (Hexed) Dental implants

Z-2453-2016
Recall number
Z-2453-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item:CNRIC

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 49 of 119

Conical EP Pick-Up Coping (Non-Hexed) Dental implants

Z-2454-2016
Recall number
Z-2454-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: CSQ17, CSQ06 and CSQ07.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 50 of 119

Conical EP Twist Lock TM Coping Dental implants

Z-2455-2016
Recall number
Z-2455-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: CIC55, CIC56 and CIC57.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 51 of 119

Conical Healing Cap Dental implants

Z-2456-2016
Recall number
Z-2456-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: MHC33

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 52 of 119

Cover Screw Dental implants

Z-2457-2016
Recall number
Z-2457-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: CS375, CS500 and CS600.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 53 of 119

Cover Screw, Headless Dental implants

Z-2458-2016
Recall number
Z-2458-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: CS275

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 54 of 119

DAL-RO Housing, Female Assembly Dental implants

Z-2459-2016
Recall number
Z-2459-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: DRTH

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 55 of 119

DAL-RO Abutment Dental implants

Z-2460-2016
Recall number
Z-2460-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 deices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: DRH20, DRH40 and DRH60

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 56 of 119

DAL-RO Threaded Female Dental implants

Z-2461-2016
Recall number
Z-2461-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: DRAF

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 57 of 119

Drill Stop Dental implants

Z-2462-2016
Recall number
Z-2462-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: DS2310, DS2315, DS2320, DS4513, DS4518 and DS458

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 58 of 119

EP Healing Abutment Dental implants

Z-2463-2016
Recall number
Z-2463-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: MHA32, MHA33, MHA34, MHA36, THA58, THA63, THA64, THA66, THA68, THA73, THA74, THA76, THA78, WTH52, WTH53, WTH54, WTH56, WTH58, WTH562, WTH563, WTH564, WTH566, WTH568, WTH572, WTH573, WTH574, WTH576, WTH578, WTH62, WTH63, WTH64, WTH66, WTH68, WTH672, WTH673, WTH674, WTH676 and WTH678.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 59 of 119

Gingihue 15 Degree Pre-Angled Post Dental implants

Z-2464-2016
Recall number
Z-2464-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: MPAP32G, MPAP34G, PAP454G, PAP462G, PAP464G, PAP472G, PAP474G, PAP552G, PAP554G, PAP562G, PAP564G, PAP572G, PAP574G, PAP662G, PAP664G, PAP672G and PAP674G.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 60 of 119

Gingihue Post Dental implants

Z-2465-2016
Recall number
Z-2465-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: MAP32G, MAP34G, APP462G, APP464G, APP472G, APP474G, WPP554G, WPP562G, WPP564G, WPP572G, WPP574G, WPP662G, WPP664G, WPP672G and WPP674G.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 61 of 119

Gold Slotted Screw Dental implants

Z-2466-2016
Recall number
Z-2466-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: GS200 and GS300.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 62 of 119

Gold -Tite Hexed Retaining Screw Dental implants

Z-2467-2016
Recall number
Z-2467-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: GS200 and GS300.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 63 of 119

Healing Abutment Dental implants

Z-2468-2016
Recall number
Z-2468-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: THA42, THA43, THA44, THA46 and THA48.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 64 of 119

Implant Cover Screw Dental implants

Z-2469-2016
Recall number
Z-2469-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: MMCS1

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 65 of 119

Implant EP Pick-Up Coping Dental implants

Z-2470-2016
Recall number
Z-2470-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IIC60, IIC75, WIP55, WIP56, WIP57, WIP66 and WIP67

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 66 of 119

Implant EP Twist Lock TM Coping Dental implants

Z-2471-2016
Recall number
Z-2471-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IIC46, IIC47, WIT56, WIT57, WIT55, WIT66 and WIT67

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 67 of 119

Implant Twist Lock TM Coping Dental implants

Z-2472-2016
Recall number
Z-2472-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IIC44.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 68 of 119

Index Coping Surgical Dental implants

Z-2473-2016
Recall number
Z-2473-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IC100.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 69 of 119

IOL Abutment and Screw Dental implants

Z-2474-2016
Recall number
Z-2474-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IOL20T, IOL55T and IOL70T

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 70 of 119

IOL Distal Extension Dental implants

Z-2475-2016
Recall number
Z-2475-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IOLDE

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 71 of 119

IOL Healing Cap Dental implants

Z-2476-2016
Recall number
Z-2476-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IOLHC

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 72 of 119

IOL Pick-Up Impression Coping Dental implants

Z-2477-2016
Recall number
Z-2477-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IOLPIC

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 73 of 119

IOL Titanium Temporary Cylinder Dental implants

Z-2478-2016
Recall number
Z-2478-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IOLTC

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 74 of 119

IOL Transfer Impression Coping Dental implants

Z-2479-2016
Recall number
Z-2479-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IOLTIC

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 75 of 119

Locator Abutment Dental implants

Z-2480-2016
Recall number
Z-2480-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: MLOA001, MLOA002, MLOA003, MLOA004, MLOA005, MLOA006, LOA001, LOA002, LOA003, LOA004, LOA005 and LOA006.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 76 of 119

Locator Abutment Impression Coping Dental implants

Z-2481-2016
Recall number
Z-2481-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: LAIC1.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 77 of 119

Certain Hex Try-in Screw (5 pk) Dental implants

Z-2482-2016
Recall number
Z-2482-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IUNITS

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 78 of 119

Certain Implant Cover Screw Dental implants

Z-2483-2016
Recall number
Z-2483-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: ICS375, ICS500 and ICS600.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 79 of 119

Certain Implant EP Twist Lock TM Coping Dental implants

Z-2484-2016
Recall number
Z-2484-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1, 648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IWIT67

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 80 of 119

Certain Implant Straight Cover Screw Dental implants

Z-2485-2016
Recall number
Z-2485-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: ICS400

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 81 of 119

Certain IOL Abutment Dental implants

Z-2486-2016
Recall number
Z-2486-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IIOL55S and IIOL70S

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 82 of 119

Certain Locator Abutment Dental implants

Z-2487-2016
Recall number
Z-2487-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IMLOA001, IMLOA002, IMLOA003, IMLOA004, IMLOA005, IMLOA006, ILOA001, ILOA002, ILOA003, ILOA004, ILOA005, and ILOA006.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 83 of 119

Certain Micromini Flat Implant Cover Screw Dental implants

Z-2488-2016
Recall number
Z-2488-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IMCSF34

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 84 of 119

Certain Non-Hexed Implant Pick-up Coping Dental implants

Z-2489-2016
Recall number
Z-2489-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IMCSF34

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 85 of 119

Certain Pick-up Coping Dental implants

Z-2490-2016
Recall number
Z-2490-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IMIC33, IIIC60, IIIC75, IWIP56, IWIP57, IWIP66 and IWIP67.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 86 of 119

Certain Preformance 15 degrees Pre-Angled Post Dental implants

Z-2491-2016
Recall number
Z-2491-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IMPAPF36, IMPAPF354 and IMPAPF356.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 87 of 119

Certain Preformance Post Dental implants

Z-2492-2016
Recall number
Z-2492-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IMPFP34, IMPFP36, IMPFP354, IMPFP356, IPFP456, IWPFP554, IWPFP556, IWPFP664 and IWPFP666.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 88 of 119

Certain Preformance Temporary Cylinder Dental implants

Z-2493-2016
Recall number
Z-2493-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IMPFTC34, IMPFTC32, IPFTC41, IPFTC42, IWPFTC51, IWPFTC52, IWPFTC61 and IWPFTC62.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 89 of 119

Certain Provide Abutment Dental implants

Z-2494-2016
Recall number
Z-2494-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IPA4140, IPA4155, IPA4240, IPA4255, IPA4340, IPA4355, IPA4440, IPA4455, IPA5140, IPA5155, IPA5240, IPA5255, IPA5340, IPA5355, IPA5440, IPA5455, IPA6140, IPA6155, IPA6240, IPA6255, IPA6340, IPA6355, IPA6440 and IPA6455.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 90 of 119

Certain Standard Abutment Dental implants

Z-2495-2016
Recall number
Z-2495-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IAB200, IAB300, IAB400, IAB550 and IAB700.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 91 of 119

Certain Straight Healing Abutment Dental implants

Z-2496-2016
Recall number
Z-2496-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: ISMHA32, ISMHA33, ISMHA34, ISMHA36, ISHA46, ISHA48, ISWHA52, ISWHA53, ISWHA54, ISWHA56, ISWHA58, ISWHA62, ISWHA63, ISWHA64, ISWHA66 and ISWHA68.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 92 of 119

Certain Straight Pick Up Coping Dental implants

Z-2497-2016
Recall number
Z-2497-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IMIC30 and IWIP60

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 93 of 119

Certain Temporary Hexed Cylinder Dental implants

Z-2498-2016
Recall number
Z-2498-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IMMTCS1, IITCS41, IWTCS51 and IWTCS61.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 94 of 119

Certain Temporary Non-Hexed Cylinder Dental implants

Z-2499-2016
Recall number
Z-2499-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IITCS42, IWTCS52 and IWTCS62.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 95 of 119

Certain Titanium Large Hexed Screw Dental implants

Z-2500-2016
Recall number
Z-2500-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: ILRGHT

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 96 of 119

Certain Twist Lock TM Coping Dental implants

Z-2501-2016
Recall number
Z-2501-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IIIC46, IIIC47, IWIT55, IWIT56 and IWIT57.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 97 of 119

Certain Twist Lock TM Straight Transfer Coping Dental implants

Z-2502-2016
Recall number
Z-2502-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IWIT50 and IWIT60.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 98 of 119

Certain Twist Lock TM Coping Dental implants

Z-2503-2016
Recall number
Z-2503-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IWIT66.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 99 of 119

Conical 17 degree Angled Abutment Dental implants

Z-2504-2016
Recall number
Z-2504-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: AC4217 and AC4417.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 100 of 119

Conical 25 degree Angled Abutment Dental implants

Z-2505-2016
Recall number
Z-2505-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: AC4225 and AC4425.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 101 of 119

Conical Abutment Dental implants

Z-2506-2016
Recall number
Z-2506-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: MCA31, MCA33, MCA34, CA001, CA002, CA004, WCA51 and WCA53.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 102 of 119

Conical Abutment Gold Standard ZR TM Dental implants

Z-2507-2016
Recall number
Z-2507-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: SCA001, SCA002, SCA003, SCA004, SCA055, SWCA51, SWCA52, SWCA53, SWCA54 and SWCA55.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 103 of 119

Conical Abutment Pick-up Coping Dental implants

Z-2508-2016
Recall number
Z-2508-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: MEC33.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 104 of 119

Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental implants

Z-2509-2016
Recall number
Z-2509-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Lot No. 1152783

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 105 of 119

Bellatek Encode Healing Abutment Dental implants

Z-2510-2016
Recall number
Z-2510-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall).

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: EHA343, EHA344, EHA346, EHA348, EHA353, EHA354, EHA356, EHA358, EHA443, EHA444, EHA446, EHA448, EHA453, EHA454, EHA456, EHA458, EHA463, EHA464, EHA466, EHA468, EHA473, EHA474, EHA476, EHA478, EHA553, EHA554, EHA556, EHA558, EHA563, EHA564, EHA566, EHA568, EHA573, EHA574, EHA576. EHA578, EHA663, EHA664, EHA666, EHA668, EHA673, EHA674, EHA676 and EHA678.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 106 of 119

Certain EP Twist Lock TM Coping Dental implants

Z-2511-2016
Recall number
Z-2511-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall).

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IMIT33

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 107 of 119

Certain Bellatek Encode Healing Abutment Dental implants

Z-2512-2016
Recall number
Z-2512-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IEHA343, IEHA344, IEHA346, IEHA348, IEHA353, IEHA354, IEHA356, IEHA358, IEHA443, IEHA444, IEHA446, IEHA448, IEHA453, IEHA454, IEHA456, IEHA458, IEHA463, IEHA464, IEHA466, IEHA468, IEHA473, IEHA474, IEHA476, IEHA478, IEHA553, IEHA554, IEHA556, IEHA558, IEHA563, IEHA564, IEHA566, IEHA568, IEHA573, IEHA574, IEHA576. IEHA578, IEHA663, IEHA664, IEHA666, IEHA668, IEHA673, IEHA674, IEHA676 and IEHA678.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 108 of 119

Certain Conical 17 degree Angled Abutment Dental implants

Z-2513-2016
Recall number
Z-2513-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IAC4217 and IAC4417

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 109 of 119

Certain Conical 25 degree Angled Abutment Dental implants

Z-2514-2016
Recall number
Z-2514-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IAC4225 and IAC4425

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 110 of 119

Certain Conical Abutment Dental implants

Z-2515-2016
Recall number
Z-2515-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IMCA31, IMCA32, IMCA33, IMCA34, ICA001, ICA002, ICA003, ICA004, IWCA51, IWCA52, IWCA53, IWCA54 and IWCA55.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 111 of 119

Certain Cover Screw Dental implants

Z-2516-2016
Recall number
Z-2516-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IMMCS1

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 112 of 119

Certain EP Healing Abutment Dental implants

Z-2517-2016
Recall number
Z-2517-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IMHA352, IMHA353, IMHA356, ITHA58, ITHA63, ITHA64, ITHA66. ITHA68, ITHA73, ITHA74, ITHA76, ITHA78, IWTH52, IWTH54, IWTH56, IWTH58, IWTH562, IWTH564, IWTH566, IWTH568, IWTH572, IWTH573, IWTH574, IWTH576, IWTH578, IWTH62, IWTH63, IWTH64, IWTH66, IWTH68, IWTH672, IWTH673, IWTH674, IWTH676 AND IWTH678.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 113 of 119

Certain EP Pick-Up Coping Dental implants

Z-2518-2016
Recall number
Z-2518-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IMIC35

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 114 of 119

Certain EP Twist Lock TM Coping Dental implants

Z-2519-2016
Recall number
Z-2519-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IMIT35

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 115 of 119

Certain Flat Implant Cover Screw Dental implants

Z-2520-2016
Recall number
Z-2520-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: ICSF41, ICSF50 and ICSF60

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 116 of 119

Certain Gingihue TM 15 degree Angled Post Dental implants

Z-2521-2016
Recall number
Z-2521-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Item: IMPAP34G

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 117 of 119

Certain Gingihue 15 degree Pre- Angled Post Dental implants

Z-2522-2016
Recall number
Z-2522-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IMPAP352G and IMPAP354G

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 118 of 119

Certain Gingihue Post Dental implants

Z-2523-2016
Recall number
Z-2523-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IMAP352G, IMAP354G, IAPP462G, IAPP464G, IAPP472G, IAPP474G, IWPP564G, IWPP572G, IWPP574G, IWPP662G, IWPP664G, IWPP672G AND IWPP674G.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

device · product 119 of 119

Certain Gingihue 15 degree Angled Post Dental implants

Z-2524-2016
Recall number
Z-2524-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,648,273 devices (all products subject to this recall)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pouches may not have been sealed during packing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouches may not have been sealed during packing.

Code information

Items: IPAP464G, IPAP472G, IPAP474G, IPAP462G, IPAP554G, IPAP562G, IPAP564G, IPAP572G, IPAP574G, IPAP662G, IPAP664G, IPAP672G AND IPAP674G.

Distribution pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.