BEUDAMED
    FDA Recall Terminated

    SpeedLink 6.0 Transverse Connector Long 50-60mm, non-sterile, 1304-60L

    Recall: Z-0032-2011 · Initiated January 1, 2009

    Recall

    Recall Number
    Z-0032-2011
    Event Number
    54527
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 1, 2009
    Posted
    October 8, 2010
    Terminated
    January 5, 2011
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    SpeedLink 6.0 Transverse Connector Long 50-60mm, non-sterile, 1304-60L

    Reason

    The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.

    Action

    The firm provided a revised surgical technique document to the Zimmer spine sales force in January, 2009. The firm will provide an Urgent Medical Device Correction notification to speedlink users through the sales force.

    Distribution

    The devices are contained in implant cases stocked by Zimmer spine and made available to the Zimmer sales force for surgeries. They are not in general distribution.

    Quantity

    23,205 Units for ALL PRODUCTS IN THIS RECALL