DePuy Orthopaedics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0061-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 27, 2014

Date Posted: October 15, 2014

Recall Number: Z-0061-2015

Event ID: 69052

Reason for Recall:

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

Status: Terminated

Product Quantity: 65 units

Code Information:

Barcode: 10603295240532 CATALOG NO. : 962004000 Lot # OSA-149328 Lot # OSA-181610 Lot # OSA-161157

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated