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U.S. Department of Health and Human Services

Class 2 Device Recall Charnley Pin Retractor and Handle Set

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  Class 2 Device Recall Charnley Pin Retractor and Handle Set see related information
Date Initiated by Firm August 27, 2014
Date Posted October 09, 2014
Recall Status1 Terminated 3 on November 17, 2015
Recall Number Z-0061-2015
Recall Event ID 69052
Product Classification Instrument, manual, surgical, general use - Product Code MDM
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.
Code Information Barcode: 10603295240532 CATALOG NO. : 962004000  Lot # OSA-149328 Lot # OSA-181610  Lot # OSA-161157
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Tia L. Holmes-Johnson
574-267-4577
Manufacturer Reason
for Recall		 The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
FDA Determined
Cause 2		 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 kearle@its.jnj.com. 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 Kearle@its.jnj.com. 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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