BEUDAMED
    FDA Recall Terminated

    Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery

    Recall: Z-0223-2020 · Initiated September 16, 2019

    Recall

    Recall Number
    Z-0223-2020
    Event Number
    83948
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    NKG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 16, 2019
    Terminated
    April 24, 2020
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery

    Reason

    The subject product measures 4.0mm in diameter instead of 3.5mm.

    Action

    On September 16, 2019, the firm distributed Urgent Medical Device Recall letters to customers, notifying them that the affected screws measure 4.0mm in diameter instead of 3.5mm. Customers should take the following actions: 1. Immediately review your inventory to identify and quarantine the subject product in a manner that ensures the subject product will not be used. 2. Complete the attached Verification Section and return to firm even if you have no product on hand. If you have product to be returned: - Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. - Return the Verification Section included with the letter with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132 - Send a copy of the completed Verification Section to DePuy Synthes by: Scan/email: [email protected] - Return any subject product within 30 business days. 3. Forward the notice to anyone in your facility that needs to be informed. 4. If any of the subject product has been forwarded to another facility, contact that facility to arrange return. 5. Keep a copy of the notice visibly posted for awareness until all product subject to this recall (removal) has been returned. While processing your return, please maintain a copy of the notice with the product subject to this recall (removal) and keep a copy for your records. If you have any questions, please call 610-719-5450 (8 am 5 pm, Eastern time, M-F) or contact your DePuy Synthes Sales Consultant.

    Distribution

    Distributed to NJ.

    Quantity

    6