FDAFDA · Food and drugs·Recall number Z-0061-2015
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.
Published October 15, 2014 · Recall initiated: August 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- 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.
- Lot
- Barcode: 10603295240532 CATALOG NO. : 962004000 Lot # OSA-149328 Lot # OSA-181610 Lot # OSA-161157
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.