BEUDAMED
    FDA Recall Open, Classified

    DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001

    Recall: Z-0101-2023 · Initiated September 27, 2022

    Recall

    Recall Number
    Z-0101-2023
    Event Number
    90918
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    JDR
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    September 27, 2022
    Posted
    October 18, 2022
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001

    Reason

    The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

    Action

    On September 27, 2022, the firm notified affected customers via urgent medical Device Recall letters. Customers were instructed to examine their inventory to determine if they have affected product and to quarantine them immediately - Customers should not use the recalled products. Customers should contact their DePuy Synthes Sales Consultant or call the customer support services at [email protected] to coordinate the return/credits of the subject products.

    Distribution

    US Nationwide distribution.

    Quantity

    196