FDA Device recall Z-2545-2014
Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left
- FDA Device
- Class II
- terminated
- Published 2014-09-03
On 2014-09-03 the FDA classified a Class II recall of Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left by Zimmer, citing 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 seg….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2545-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-30 |
| Published | 2014-09-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
Reason
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.
Identifiers
| code_info | 00-5926-014-01; Lot 62455332 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2545-2014%22
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