Exact FDA event identifier

Event 81758

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

Event summary

Timeline bucket: November 28, 2018
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

2 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 2

Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals

Z-0734-2019

Recall number: Z-0734-2019
Initiated: November 28, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 971 i nTotal

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is a potential for silicone shedding during cleaning and sterilization.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for silicone shedding during cleaning and sterilization.

Code information

Lot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512868

Distribution pattern

Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.

device · product 2 of 2

Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals

Z-0735-2019

Recall number: Z-0735-2019
Initiated: November 28, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 971 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is a potential for silicone shedding during cleaning and sterilization.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for silicone shedding during cleaning and sterilization.

Code information

Lot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512867 512868

Distribution pattern

Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.