BEUDAMED
    FDA Enforcement Class II 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 · Reported July 11, 2012

    Enforcement

    Recall Number
    Z-1934-2012
    Event ID
    62240
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 11, 2012
    Initiation Date
    March 7, 2012
    Classification Date
    July 3, 2012
    Termination Date
    August 8, 2012
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    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.

    Code Info

    All distributed lot numbers and serial numbers

    Distribution

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

    Quantity

    15