CHARNLEY recallZ-0061-2015 · DePuy Orthopaedics, Inc. · initiated Aug 27, 2014
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
FDA root cause category: Mixed-up of materials/components
What the company is doing
The firm, Depuy Synthes, sent an "URGENT INFORMATION - RECALL NOTICE" dated August 27, 2014 to their consignees. The recall notification included a description of the reason for recall, affected product, clinical implications, and instructions for responding to the formal recall notification. The customers were instructed to cease using the affected components immediately, quarantine all affected components in a manner that ensures the affected components are not used; return affected devices immediately to your DePuy; if any affected product has been forwarded to another facility, contact that facility immediately to communicate recall and arrange return; maintain awareness and copy of this notice, and complete and return the Reconciliation forms via fax to 574-371-4939 or emailed to [email protected]. For questions about the device recall information provided, please contact Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT) or email [email protected]. For product-related questions, please contact your local DePuy Orthopaedics, Inc. Sales Consultant. For clinical questions from hospitals/user facilities, please contact DePuy Orthopaedics, Inc. Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. - 5 p.m. EDT).
Recall details
- Recall number
- Z-0061-2015
- Status
- Terminated
- Initiated by the company
- Aug 27, 2014
- Posted by the FDA
- Oct 9, 2014
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 65 units
- Product code
- MDM
- 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.
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.
Code information (models, lots, serial numbers)
Barcode: 10603295240532 CATALOG NO. : 962004000 Lot # OSA-149328 Lot # OSA-181610 Lot # OSA-161157
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CHARNLEY 9620-04-000Depuy International Ltd · RETRACTOR1 recall2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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