BEUDAMED
    FDA Recall Terminated

    S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.

    Recall: Z-1934-2012 · Initiated March 7, 2012

    Recall

    Recall Number
    Z-1934-2012
    Event Number
    62240
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    HWW
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 7, 2012
    Posted
    July 3, 2012
    Terminated
    August 8, 2012
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.

    Reason

    Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments.

    Action

    The firm initiated their recall of this product by issuing an "Important Product Removal Notification" letter to all consignees dated March 7, 2012. The letter described the problem, advised them not to use the product, and instructed consignees to return the instruments to the recalling firm with the attached Distribution Inventory Sheet. Customer Service may be contacted if questions at 1-866-229-3002.

    Distribution

    Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .

    Quantity

    15