Z-0061-2015Class II

Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor...

Name: Z-0061-2015 Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor...
Creator: DePuy Orthopaedics, Inc.
Published: 2014-08-27
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2014-08-27 / Terminated

FDA source

DePuy Orthopaedics, Inc. began a recall of Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion... on 2014-08-27. FDA classified it as Class II and gives the reason as "The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0061-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-27
Posted: 2014-10-09
Terminated: 2015-11-17
Recalling firm: Depuy Orthopaedics Inc.
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.
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
FDA root cause: Mixed-up of materials/components
Action: 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).
Quantity in commerce: 65 units
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 codes and lots: Barcode: 10603295240532 CATALOG NO. : 962004000 Lot # OSA-149328 Lot # OSA-181610 Lot # OSA-161157

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0061-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0061-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09

Product code MDM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)