BEUDAMED
    FDA Recall Open, Classified

    Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716

    Recall: Z-1616-2024 · Initiated March 22, 2024

    Recall

    Recall Number
    Z-1616-2024
    Event Number
    94291
    Firm
    EBI, LLC
    FEI Number
    2242816
    Product Code
    LOF
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 22, 2024
    Posted
    April 23, 2024
    Address
    1 Gatehall Dr, Ste 303, Parsippany, NJ, 07054-4514

    Description

    Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716

    Reason

    Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment

    Action

    ZimVie issued Urgent Medical Device Correction letter to Patients, Physicians, Sales Representatives on 3/22/24 . Letter states reason for recall, health risk and action to take: 1. Review this notification for awareness of the contents. 2. Before each use, inspect your device s lead wires (black cable) for damage. If found to be damaged, contact Customer Service at 1-800-526-2579 x 6000 for a complimentary replacement. 3. Complete the Acknowledgement and Receipt Form either by scanning the QR code on the postcard included with this letter and completing the online form or mailing back the completed postcard. To complete your Acknowledgement, you will need to include your Unique Patient Reference Number included on the top of the first page of this letter. This acknowledgement should be completed even if you do not have affected product. 4. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-526-2579 x 6000. Customer Service Representatives are available from 8:30 am to 5:00 pm (EST), Monday through Friday. At other times, please leave a clear message for a return call by the next business day. Alternatively, your questions may be emailed to [email protected].

    Distribution

    US Nationwide distribution.