—#151963

Product

DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Unknown

Why it was recalled

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.

Root cause (FDA determination)

Vendor change control

Action the firm took

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

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA

Timeline

Recall initiated: 2017-01-06
Terminated: 2019-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151963. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.