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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75761

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

Open FDA event record

Event summary

Timeline bucket
September 14, 2016
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

36 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 36

BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0828-2017
Recall number
Z-0828-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
127

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPAC3217 Lot # 2015111777

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 2 of 36

BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0829-2017
Recall number
Z-0829-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
53

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPAC3417 Lot # 2015111355

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 3 of 36

BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0830-2017
Recall number
Z-0830-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
27

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPAC3530 Lot # 2016030311

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 4 of 36

BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0831-2017
Recall number
Z-0831-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
735

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPAC4217 Lot # 2015112156, 2015112157, 2015112158, 2015112159, 2015120466, 2016010159, 2016031210, 2016040438, and 2016061525

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 5 of 36

BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0832-2017
Recall number
Z-0832-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
431

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPAC4330 Lot # 2015111372, 201611713, 2016020101, and 2016050131

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 6 of 36

BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0833-2017
Recall number
Z-0833-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
150

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPAC4417 Lot # 2016011141, 2016020088, and 2016031214

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 7 of 36

BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0834-2017
Recall number
Z-0834-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
228

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPAC4530 Lot # 2015111373, 2015111778, 201520886, 2015120887, and 2016021477

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 8 of 36

BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0835-2017
Recall number
Z-0835-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
50

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPC342 Lot # 2015121064 and 2016030816

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 9 of 36

BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0836-2017
Recall number
Z-0836-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
101

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPC342U Lot # 2016020057,

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 10 of 36

BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0837-2017
Recall number
Z-0837-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
64

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPC344U Lot # 2016011182 and 2016041553

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 11 of 36

BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0838-2017
Recall number
Z-0838-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
123

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPC441 Lot # 2016021500

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 12 of 36

BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0839-2017
Recall number
Z-0839-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
450

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPC441U Lot # 2015112073, 2016040049, 2016040914, and 2016042048

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 13 of 36

BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0840-2017
Recall number
Z-0840-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
108

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPC442 Lot # 2016030811

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 14 of 36

BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0841-2017
Recall number
Z-0841-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
525

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPC442U Lot # 2015110458, 2015111460, 2015121066, 2016020509, and 2016042047

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 15 of 36

BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0842-2017
Recall number
Z-0842-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
46

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPC443U Lot # 2015120624

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 16 of 36

BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0843-2017
Recall number
Z-0843-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
108

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # ILPC444U Lot # 201602051 and 2016040048

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 17 of 36

BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0844-2017
Recall number
Z-0844-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
20

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPAC3330 Lot # 2015120640

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 18 of 36

BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0845-2017
Recall number
Z-0845-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
4

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPAC3530 Lot # 2015110514

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 19 of 36

BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0846-2017
Recall number
Z-0846-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
246

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPAC4217 Lot # 2015110506, 2016030834, 2016042066, 2016042068

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 20 of 36

BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0847-2017
Recall number
Z-0847-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
175

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPAC4330 Lot #'s 2016010803 and 2016030830

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 21 of 36

BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0848-2017
Recall number
Z-0848-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
216

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPAC4417 Lot #'s 2015110513, 2016010805 and 2016050344

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 22 of 36

BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0849-2017
Recall number
Z-0849-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
160

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPC441 Lot # 2015110365

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 23 of 36

BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0850-2017
Recall number
Z-0850-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
204

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPC441U Lot # 2015120620

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 24 of 36

BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0851-2017
Recall number
Z-0851-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
137

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPC442U Lot # 2015101819

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 25 of 36

BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0852-2017
Recall number
Z-0852-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
50

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPC443 Lot # 201611726

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 26 of 36

BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0853-2017
Recall number
Z-0853-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
191

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPC443U Lot # 2015120622

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 27 of 36

BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0854-2017
Recall number
Z-0854-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
124

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPC444U Lot # 2016030294

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 28 of 36

BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0855-2017
Recall number
Z-0855-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
391

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPCHC Lot # 2016030791, 2016030792, 2016030793, and 2016060693

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 29 of 36

BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0856-2017
Recall number
Z-0856-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
28

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPCPIC1 Lot # 2015110454

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 30 of 36

BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0857-2017
Recall number
Z-0857-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
458

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPCPIC2 Lot #'s 2015112084, 2016011162, 2016011163, 2016031299, 2016041629 and 2016042021

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 31 of 36

BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0858-2017
Recall number
Z-0858-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
270

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part #LPCPTC2 Lot #'s 2016011174, 2016011175 and 2016011178

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 32 of 36

BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0859-2017
Recall number
Z-0859-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
60

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPCQB Lot # 2016040022

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 33 of 36

BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0860-2017
Recall number
Z-0860-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
108

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPCTC1 Lot # 2016030247

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 34 of 36

BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0861-2017
Recall number
Z-0861-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,371

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPCTC2 Lot's # 2015111121, 2015120492, 2015120495, 2015120497, 2015121108, 2015121114, 2015121115, 2016011524, 2016031197, 2016031875, 2016031878, 2016050008, 2016060232, 2016060233, 2016060234, and 2016062347

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 35 of 36

BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0862-2017
Recall number
Z-0862-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
191

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPCTIC2 Lots # 2015110366, 2015110389, 2015110450, 2015110451, 2015110452, 2016021488, 2016021489, 2016021490, and 2016040888

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

device · product 36 of 36

BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Z-0863-2017
Recall number
Z-0863-2017
Initiated
September 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
1,633

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A limited number of product pouches may not have been sealed during packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

Code information

Part # LPCTSH Lots # 2016021930, 2016022074, 2016031247, 2016031248, 2016040024, 2016040025, 2016040064, 2016040898, 2016041632, 2016041635, 2016042030, and 2016042036

Distribution pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden