Charnley PN Retract & Handle — Class II medical device recall Z-0061-2015
Terminated recall by DePuy Orthopaedics, Inc., reported 2014-10-15, distributed nationwide. The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
| Recall number | Z-0061-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-08-27 |
| Classified | 2014-10-09 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2015-11-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL, GB, IE, IN, JP, NZ, RU, SA, SG |
| Quantity | 65 units |
| UPC / GTIN / UDI-DI | 10603295240532 |
| Lot numbers | OSA-149328, OSA-161157, OSA-181610 |
| Model numbers | 962004000 |
Product
Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure.
Reason for recall
The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
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-0061-2015. 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.