AGC 2000 LP Patella — Class II medical device recall Z-0627-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-02-21, distributed nationwide. The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the p
| Recall number | Z-0627-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-08-25 |
| Classified | 2018-02-15 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 28 devices |
| UPC / GTIN / UDI-DI | 00880304240230 |
| Lot numbers | 305330 |
| Model numbers | 150802 |
Product
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
Reason for recall
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0627-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.