BEUDAMED
    FDA Recall Terminated

    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

    Recall: Z-1429-2022 · Initiated November 18, 2020

    Recall

    Recall Number
    Z-1429-2022
    Event Number
    90526
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 18, 2020
    Terminated
    December 23, 2024
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

    Reason

    Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.

    Action

    An Urgent Field Safety Notification was issued November 18, 2020 sent USPS certified mail to distributors regarding removal of Ennovate Removal Key Short (SZ380) from the field. The affected Ennovate MIS Removal Key Short (SZ380R) in the field is to be exchanged with an improved design version under the same article number manufactured after June 01, 2020. Distributors are to identify and notify customers of this action. Distributors and customers are to identify the affected version in inventory and return it to Aesculap and submit the Acknowledgment Form via email at [email protected].

    Distribution

    United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & TX.

    Quantity

    17