BEUDAMED
    FDA Recall Terminated

    Strauss Penis Clamp 130MM/General Instruments

    Recall: Z-1359-2018 · Initiated February 16, 2018

    Recall

    Recall Number
    Z-1359-2018
    Event Number
    79656
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    FHA
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    February 16, 2018
    Terminated
    June 30, 2020
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    Strauss Penis Clamp 130MM/General Instruments

    Reason

    The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

    Action

    An Urgent Medical Device Recall notification will be sent via Fed-ex overnight to our customers on February 16, 2018. Customers will be required to review the recall notification letter in its entirety and ensure all users in the organization are informed about this recall and the affected products

    Distribution

    nationwide