Class 2 Device Recall DePuy Synthes orthopedic instruments

• Date Initiated by Firm: January 06, 2017
• Create Date: June 08, 2017
• Recall Status: Terminated on May 15, 2019
• Recall Number: Z-2317-2017
• Recall Event ID: 76023
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
• Code Information: Unknown
• Recalling Firm/ Manufacturer: DePuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: Tai L. Holmes-Johnson; 574-371-4577
• Manufacturer Reason for Recall: Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.
• FDA Determined Cause: Vendor change control
• Action: DePuy Synthes sent an URGENT INFORMATION  RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS dated January 6, 2017, to all affected customers. . Customerss were instructed to identify all medical facilities that may have used or received the affected instruments and identify the modified instruments used at each facility. This information was to be used to generate Reconciliation Forms for each impacted Medical Facility. The Reconciliation Forms and URGENT INFORMATION  RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS recall notifications were then delivered by DePuy Synthes Sales Consultants to the affected medical facilities. Instructions in the URGENT INFORMATION  RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS provided to the medical facilities included the following: Please take the following actions: " Please immediately cease using the modified instruments identified in the attached Reconciliation Form. Your U.S. DePuy Synthes Sales consultant will work with your facility to locate and replace any affected instruments. " If your facility is using an instrument that was created or modified by a DePuy Distributor at the request of a surgeon, and it is not listed on the attached Reconciliation Form, please contact your DePuy Synthes Sales Consultant for an evaluation to determine if the instrument should be returned and replaced. WI-9956 | Rev 5 | Attachment B2 " Return Affected Instruments: o Medical facilities are to determine if any of the recalled instruments are still on hand by working with your U.S. DePuy Synthes Sales Consultant, and return affected devices immediately to their U.S. DePuy Synthes Sales Consultant or return them to DePuy Orthopaedics, Inc. for credit following normal purchasing procedures. o Note: These instruments may be on consignment at your facility. " Reconciliation Form: Complete the Reconciliation Form and return to your U.S. DePuy Synthes Sales Consultant or
• Quantity in Commerce: 345
• Distribution: Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA
• 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.