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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79095

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

Open FDA event record

Event summary

Timeline bucket
August 25, 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

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

AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.

Z-0627-2018
Recall number
Z-0627-2018
Initiated
August 25, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
28 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.

Code information

Model No. 150802: Lot No. 305330 (UDI (01)00880304240230(17)220506(10)305330), 305340 ((01)00880304240230(17)220506(10)305330), 305350 ((01)00880304240230(17)220517(10)305350), 356750 ((01)00880304240230(17)220523(10)356750).

Distribution pattern

US Nationwide Distribution to IN, MO, NY, TX.

device · product 2 of 2

AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.

Z-0628-2018
Recall number
Z-0628-2018
Initiated
August 25, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
11 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.

Code information

Model No. 150804: Lot No. 088080 ((01)00880304240247(17)220606(10)088080), 305410 ((01)00880304240247(17)220601(10)305410).

Distribution pattern

US Nationwide Distribution to IN, MO, NY, TX.