BEUDAMED
    FDA Recall Terminated

    OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications.

    Recall: Z-0417-2012 · Initiated November 1, 2011

    Recall

    Recall Number
    Z-0417-2012
    Event Number
    60447
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KRO
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    November 1, 2011
    Posted
    January 11, 2012
    Terminated
    September 10, 2012
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications.

    Reason

    Biomet has initiated this action following an investigation which identified that Part 150367, (OSS Cemented 1M Stem 13x150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem 14x150).

    Action

    Biomet, Inc. sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 1, 2011 to the one distributor with the affected product. The letter described the product, problem, and actions to be taken by the customer. The letter instructs the customer to immediately locate and remove the affected product from inventory. Additionally, the customer was asked to complete and return a Response Form via fax to 574-372-1683. Call 574-372-3983 for questions related to this notice.

    Distribution

    Distributed only in The Netherlands.

    Quantity

    3 units & 1 pending release