BEUDAMED
    FDA Recall Terminated

    AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.

    Recall: Z-1447-2022 · Initiated September 8, 2020

    Recall

    Recall Number
    Z-1447-2022
    Event Number
    90502
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 8, 2020
    Terminated
    April 10, 2024
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.

    Reason

    Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.

    Action

    An Urgent Medical Device Removal Notification issued September 08, 2020 sent via USPS certified mail. The notice identifies the affected part numbers S4C CROSS CONNECTOR SW112T, SW113T, SW114T, SW115T, SW116T and SW117T and asks distributors and customers to identify existing inventory, quarantine, and return affected inventory. If further distributed, identify and notify customers. The notice includes an acknowledgement form to be completed and returned to Aesculap Inc. via email at [email protected]. Questions are to be directed to Lindsay Chromiak, Manager, QA Compliance and Vigilance (610) 984-9072.

    Distribution

    United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.

    Quantity

    20