BEUDAMED
    FDA Recall Open, Classified

    Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

    Recall: Z-0008-2023 · Initiated August 30, 2022

    Recall

    Recall Number
    Z-0008-2023
    Event Number
    90842
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    JDR
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    August 30, 2022
    Posted
    October 6, 2022
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

    Reason

    Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound

    Action

    DePuy Synthes issued Urgent Medical Device Recall (Removal) letter on 8/30/22. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have the subject product and quarantine. DO NOT USE THE SUBJECT PRODUCT. 2. Contact your DePuy Synthes Sales Consultant or call the customer support services at 1-800-255-2500 to coordinate the return/credits of the subject product. 3. Review, complete, sign, and return the attached Business Response Form (page 3 of this letter) to [email protected] within 3 business days of receipt of this notification. Please include in the email subject: FA 2154225: 2022 Hammertoe CCI Kit. " Please complete the attached Business Response Form even if you do not have the subject product on hand. 4. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). 5. If any of the subject product has been forwarded to another facility, contact that facility and provide them with this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your records. Inquiries please do not hesitate to contact your DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.

    Distribution

    US Nationwide distribution.

    Quantity

    191 units