Exact FDA event identifier

Event 78167

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

Event summary

Timeline bucket: June 05, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Zimmer Biomet, Inc.

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

10 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 10

Lateral Troch Plate Full Crimp - 254mm, model # 350837

Z-0296-2018

Recall number: Z-0296-2018
Initiated: June 05, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

label could be incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Code information

Lot Number: 340530

Distribution pattern

Nationwide in US; Internationally Argentina, Netherlands & Canada

device · product 2 of 10

Lateral Troch Plate Full Crimp - 254mm, model # 350838

Z-0297-2018

Recall number: Z-0297-2018
Initiated: June 05, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

label could be incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Code information

Lot Number: 406590

Distribution pattern

Nationwide in US; Internationally Argentina, Netherlands & Canada

device · product 3 of 10

COMP 12MM HUM FRAC STEM MACRO, model # 11-113562

Z-0298-2018

Recall number: Z-0298-2018
Initiated: June 05, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

label could be incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Code information

Lot Number: 529890

Distribution pattern

Nationwide in US; Internationally Argentina, Netherlands & Canada

device · product 4 of 10

COMP PRIMARY STEM 8MM MINI, model # 113628

Z-0299-2018

Recall number: Z-0299-2018
Initiated: June 05, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

label could be incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Code information

Lot Number: 523080

Distribution pattern

Nationwide in US; Internationally Argentina, Netherlands & Canada

device · product 5 of 10

ECHO POR FMRL NC 9X125, model # 192009

Z-0300-2018

Recall number: Z-0300-2018
Initiated: June 05, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

label could be incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Code information

Lot Number: 410150

Distribution pattern

Nationwide in US; Internationally Argentina, Netherlands & Canada

device · product 6 of 10

CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064

Z-0301-2018

Recall number: Z-0301-2018
Initiated: June 05, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

label could be incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Code information

Lot Number: 854540

Distribution pattern

Nationwide in US; Internationally Argentina, Netherlands & Canada

device · product 7 of 10

CER BIOLOXD OPTION HD 32MM, model # 650-1056

Z-0302-2018

Recall number: Z-0302-2018
Initiated: June 05, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

label could be incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Code information

Lot Number: 843260

Distribution pattern

Nationwide in US; Internationally Argentina, Netherlands & Canada

device · product 8 of 10

OSS CEMENTED IM STEM 12X150, model # 150366

Z-0303-2018

Recall number: Z-0303-2018
Initiated: June 05, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

label could be incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Code information

Lot Number: 71180

Distribution pattern

Nationwide in US; Internationally Argentina, Netherlands & Canada

device · product 9 of 10

RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817

Z-0304-2018

Recall number: Z-0304-2018
Initiated: June 05, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

label could be incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Code information

Lot Number: 856460

Distribution pattern

Nationwide in US; Internationally Argentina, Netherlands & Canada

device · product 10 of 10

RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828

Z-0305-2018

Recall number: Z-0305-2018
Initiated: June 05, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

label could be incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Code information

Lot Number: 856550

Distribution pattern

Nationwide in US; Internationally Argentina, Netherlands & Canada