BEUDAMED
    FDA Recall Open, Classified

    D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.

    Recall: Z-1278-2024 · Initiated October 6, 2023

    Recall

    Recall Number
    Z-1278-2024
    Event Number
    93938
    Firm
    Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany
    FEI Number
    3007264034
    Product Code
    HCI
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 6, 2023
    Posted
    March 11, 2024

    Description

    D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.

    Reason

    Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

    Action

    Reportable Event - Removal letters dated October 6, 2023 were sent to customers. Customers were instructed to return all product subject to recall and to notify any of their customers as well. Please return items for the attention of one of the PRRCs provided to ensure quick processing and assignment to the case. If you have any questions, please contact Mr. Sven Lazic ([email protected] +49 (0) 7461 96643 - 20) or Ms. Kim Maier ([email protected] or +49 (0) 7461 96643 - 21).

    Distribution

    US Nationwide distribution in the state of ME.

    Quantity

    63 units