Zimmer Gender Solution Patello-Femoral Joint — Class II medical device recall Z-2545-2014
Terminated recall by Zimmer, Inc., reported 2014-09-03, distributed nationwide. Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving
| Recall number | Z-2545-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-07-30 |
| Classified | 2014-08-25 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2015-01-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, FR, GB, JP, TW |
| Quantity | 15 units |
| Lot numbers | 62455332 |
Product
Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
Reason for recall
Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segregated and were subsequently issued to final manufacturing under Part 00-5926-014-01; lot 62455332. A forged lap is a defect that forms when metal folds over itself during forging.
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-2545-2014. 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.