BEUDAMED
    FDA Recall Terminated

    REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument

    Recall: Z-0925-2013 · Initiated February 5, 2013

    Recall

    Recall Number
    Z-0925-2013
    Event Number
    64354
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 5, 2013
    Posted
    March 8, 2013
    Terminated
    September 30, 2013
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument

    Reason

    The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes.

    Action

    BIOMET sent an Urgent Recall Notice beginning February 13, 2013, to all affected customers. The notice included possible adverse events and directions to locate and remove identified devices by returning a Fax Back Response Form to 574-372-1683 and obtaining an RGA # prior to return of product to Biomet, Inc. 56 East Bell Drive Warsaw, IN 46580. Questions should be directed to 574 372-1570 M-F, 8 a.m.-5.p.m. For questions regarding this recall call 574-267-6639, ext 1676.

    Distribution

    Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile

    Quantity

    58