BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2317-2017 · Initiated January 6, 2017

    Recall

    Recall Number
    Z-2317-2017
    Event Number
    76023
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    January 6, 2017
    Terminated
    May 15, 2019
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

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

    Reason

    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.

    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

    Distribution

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

    Quantity

    345