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.
Reported: October 15, 2014 Initiated: August 27, 2014 #Z-0061-2015
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.
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units Affected
- 65 units
- Distribution
- Worldwide Distribution: US (Nationwide) including states of: AR, CA, CO, CT, IL, MA, NC, OH, PA, TN, TX, UT, VA, WA, WI; and Internationally to: AUSTRALIA, CHILE, UK, INDIA, IRELAND, JAPAN, NEW ZEALAND, RUSSIA, SINGAPORE, and SAUDI ARABIA.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 65 units.
Why was this product recalled? ▼
The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 15, 2014. Severity: Moderate. Recall number: Z-0061-2015.
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