BEUDAMED
    FDA Recall Terminated

    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

    Recall: Z-1428-2022 · Initiated July 13, 2020

    Recall

    Recall Number
    Z-1428-2022
    Event Number
    90503
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 13, 2020
    Terminated
    April 26, 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.

    Action

    An Urgent Field Safety Notification was issued July 13, 2020 sent USPS certified mail to distributors. The notification identified the product as Ennovate Removal Key (SZ380R) and addressed correct usage of said device, referencing section K of the Surgical Technique. Distributors are to identify and notify customers if further distributed. Distributors and customers are to review the notice, notify end users, and return the "Medical Device Field Safety Notification Form" to Aesculap via email at [email protected].

    Distribution

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

    Quantity

    16