DePuy Orthopaedics, Inc.: 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

Is my product affected?

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 proc

• UPC 10603295240532

Check against the official notice below — it lists the full affected range.

What happened

DePuy Orthopaedics, Inc. is recalling the Charnley PN Retract & Handle (Catalog No. 962004000) due to a defect where the small extraction peg breaks from the pin. This surgical instrument is used to facilitate the insertion and extraction of pins during orthopedic procedures. A total of 65 units have been affected and were distributed worldwide, including to multiple U.S. states and countries such as Australia, Canada, Chile, India, Ireland, Japan, New Zealand, Russia, Singapore, Saudi Arabia, and the UK. The affected units are identified by specific lot numbers: OSA-149328, OSA-181610, and OSA-161157.

The recall notice does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.

Details from the source

Reason for recall: The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin. 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. Quantity: 65 units Lot/code info: Barcode: 10603295240532 CATALOG NO. : 962004000 Lot # OSA-149328 Lot # OSA-181610 Lot # OSA-161157

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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