Home / Recalls / Medical Devices
DePuy Orthopaedics, Inc. recalls Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Hand
Recalled October 15, 2014 · FDA recall Z-0061-2015 · DePuy Orthopaedics
Hazard
The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin. · FDA Class II
Units
65 units
Sold at
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.
Description
The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
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.
Manufacturer(s)
DePuy Orthopaedics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →