BEUDAMED
    FDA Recall Terminated

    Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System... Size: 3.5mm x 14.0 mm Locking Cortical Screw... REF COL-3140-S LOT W46772... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR ". Product is used as an orthopedic implant.

    Recall: Z-2135-2008 · Initiated July 9, 2007

    Recall

    Recall Number
    Z-2135-2008
    Event Number
    48457
    Firm
    Acumed LLC
    FEI Number
    1000125930
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 9, 2007
    Posted
    September 11, 2008
    Terminated
    February 3, 2010
    Address
    5885 NW Cornelius Pass Rd, Hillsboro, OR, 97124-9370

    Description

    Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System... Size: 3.5mm x 14.0 mm Locking Cortical Screw... REF COL-3140-S LOT W46772... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR ". Product is used as an orthopedic implant.

    Reason

    Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly.

    Action

    The firm issued a Product Removal notification on 8-9-2007. The notification was reportedly sent by either FAX or e-mail. The firm notified consignees of the issue and gave the consignees the choice of returning the screws. The notification did not include any instructions for a sub-recall. If you have any questions contact Jason Gozdecki at 1-888-627-9957.

    Distribution

    Class III Recall - Worldwide Distribution --- USA including countries of UK and Japan.

    Quantity

    400 screws