BEUDAMED
    FDA Recall Terminated

    djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair

    Recall: Z-2146-2012 · Initiated July 16, 2012

    Recall

    Recall Number
    Z-2146-2012
    Event Number
    62561
    FEI Number
    1000116912
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    July 16, 2012
    Posted
    August 6, 2012
    Terminated
    December 4, 2012
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair

    Reason

    One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.

    Action

    DJO Global sent an Urgent Field Safety Notice dated July 16, 2012, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the notice to all thoe who need to be aware within their organization or to any other organization where the potentially affected product was transferred, contact customers to place a replacement order and receive an RMA number, and return all affected devices using the RMA number. For questions customers should call 512-834-6255. For questions regarding this recall call 512-832-9500.

    Distribution

    Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.

    Quantity

    18 devices