Recall Z-0061-2015— DePuy Orthopaedics, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2014-08-27, terminated 2015-11-17. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-27
- Terminated
- 2015-11-17
- Firm location
- Warsaw, IN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.