FDA Device recall Z-0061-2015
Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd
- FDA Device
- Class II
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class II recall of Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd by Depuy Orthopaedics, citing the small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0061-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-27 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
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
The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
Identifiers
| code_info | Barcode: 10603295240532 CATALOG NO. : 962004000 Lot # OSA-149328 Lot # OSA-181610 Lot # OSA-161157 |
|---|
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-0061-2015%22
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