BEUDAMED
    FDA Recall Terminated

    Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central Drive, McKinney, TX 75068-8207. Product includes handle, stylet, cannula, probe, probe guide, and universal cap. Cannula is available as an 8 gauge needle or 11 gauge needle.

    Recall: Z-0590-2011 · Initiated October 18, 2010

    Recall

    Recall Number
    Z-0590-2011
    Event Number
    57011
    Firm
    Orthofix Inc
    FEI Number
    2183449
    Product Code
    LWE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 18, 2010
    Posted
    December 10, 2010
    Terminated
    February 28, 2011
    Address
    3451 Plano Parkway, Lewisville, TX, 75056-9453

    Description

    Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central Drive, McKinney, TX 75068-8207. Product includes handle, stylet, cannula, probe, probe guide, and universal cap. Cannula is available as an 8 gauge needle or 11 gauge needle.

    Reason

    Outer cartons for the product may be labeled with incorrect needle gauge.

    Action

    Orthofix issued an Urgent Product Recall letter dated October 14, 2010 to consignees. Customers were instructed to inspect their inventory, and remove and return affected product to the firm. Replacement needles will be provided. Orthofix account representatives can be contacted at 1 888 298 5700, and Orthofix Regulatory Affairs can be contacted at 1 214 937 2061.

    Distribution

    Worldwide Distribution - USA, including the states of AL, AR, CA, CT, FL, LA, MI, MO, NC, NJ, NY, PA, SC, and TX, and the country of Spain.

    Quantity

    274