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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67183

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

Open FDA event record

Event summary

Timeline bucket
July 22, 2013
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

5 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 5

Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

Z-1167-2014
Recall number
Z-1167-2014
Initiated
July 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
21

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

Code information

SGKIT (SGTRAY)

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.

device · product 2 of 5

Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

Z-1168-2014
Recall number
Z-1168-2014
Initiated
July 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
170

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

Code information

SGTIKIT (SGTTRAY)

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.

device · product 3 of 5

Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

Z-1169-2014
Recall number
Z-1169-2014
Initiated
July 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
541

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

Code information

NCATDO aka CATD0 (PSDT1)

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.

device · product 4 of 5

Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

Z-1170-2014
Recall number
Z-1170-2014
Initiated
July 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
250

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

Code information

NCATD0C (PSDT1)

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.

device · product 5 of 5

Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

Z-1171-2014
Recall number
Z-1171-2014
Initiated
July 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
181

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

Code information

NPSDK0 aka PSKDO (PSKDT1)(

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.