BEUDAMED
    FDA Recall Terminated

    AOS Trochanteric Nail, 12mm x 17cm x 130, Product Part Number: 1041-170.

    Recall: Z-1189-2010 · Initiated January 14, 2010

    Recall

    Recall Number
    Z-1189-2010
    Event Number
    54538
    Firm
    Advanced Orthopaedic Solutions Inc
    FEI Number
    3009833755
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 14, 2010
    Posted
    March 22, 2010
    Terminated
    April 26, 2012
    Address
    386 Beech Ave, Torrance, CA, 90501

    Description

    AOS Trochanteric Nail, 12mm x 17cm x 130, Product Part Number: 1041-170.

    Reason

    The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.

    Action

    The recall was initiated with the firm forwarding a recall notice with attached customer response form on January 14, 2010 to the affected consignees. The recall notice informed the consignees of the reason for recall and gave them three steps to follow to inspect the affected Short Trochanteric Nail products. Consignees were provided with product return instruction for any incorrectly bent products found during their inspection. Customers with questions are instructed to contact the firm at (310) 533-9966.

    Distribution

    Nationwide and Japan

    Quantity

    340