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Recall Observatory FDA recall evidence

Device 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.

Z-0061-2015

August 27, 2014

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 69052
Status
Terminated
Classification
Class II
Quantity
65 units
Official record key
device-enforcement:Z-0061-2015

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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