BEUDAMED
    FDA Recall Open, Classified

    Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462

    Recall: Z-2645-2023 · Initiated August 23, 2023

    Recall

    Recall Number
    Z-2645-2023
    Event Number
    92955
    Firm
    Stryker Corporation
    FEI Number
    2936485
    Product Code
    MBI
    Status
    Open, Classified
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    August 23, 2023
    Posted
    September 28, 2023
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462

    Reason

    Expired Product distributed

    Action

    On August 23, 2023, Stryker issued an "Urgent Medical Device Recall Notification" to affected consignees via . Stryker asked consignees to take the following actions: Actions needed: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Check all inventory to determine if any devices from the affected product list are located at your facility. Response is required by September 30, 2023. 3. If affected product is found, quarantine and discontinue use of the recalled devices. Please complete the response form on Appendix A of this notice and return devices back to Stryker Endoscopy. 4. If no product is found, complete acknowledgement form and return it back to Stryker.

    Distribution

    US Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ, NM, CA.

    Quantity

    96 units