Z-0061-2015 Class II Terminated
FDA device recall Z-0061-2015 was initiated by DePuy Orthopaedics, Inc. on Aug 27, 2014 and is designated Class II. Reason for recall: The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin. The recall status is terminated (terminated Nov 17, 2015). Affected quantity: 65 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 15, 2014
- Initiation Date
- Aug 27, 2014
- Termination Date
- Nov 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65 units
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.
Reason for Recall
The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
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.
Code Information
Barcode: 10603295240532 CATALOG NO. : 962004000 Lot # OSA-149328 Lot # OSA-181610 Lot # OSA-161157
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0061-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026