BEUDAMED
    FDA Recall Terminated

    GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories

    Recall: Z-1218-2017 · Initiated January 9, 2017

    Recall

    Recall Number
    Z-1218-2017
    Event Number
    76210
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 9, 2017
    Posted
    February 16, 2017
    Terminated
    June 14, 2017
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories

    Reason

    Generators may have a faulty component which could impact the proper functioning of the device.

    Action

    Aesculap mailed an Urgent Medical Device Recall Notification letter dated January 9, 2017, to all affected customers. The notification letter advised customers to discontinue use and quarantine the affected unit if found. Customers were asked to complete the enclosed Acknowledgement form, list the serial number in their possession and return via fax at the number that was provided in the notification. For further questions, please call (800) 258-1946.

    Distribution

    USA (nationwide Distribution).

    Quantity

    24 generators