BEUDAMED
    FDA Recall Terminated

    OSS AVL Poly Tibial Bushing Set OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedures.

    Recall: Z-1143-2012 · Initiated February 7, 2012

    Recall

    Recall Number
    Z-1143-2012
    Event Number
    61100
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    February 7, 2012
    Posted
    March 2, 2012
    Terminated
    February 6, 2013
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    OSS AVL Poly Tibial Bushing Set OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedures.

    Reason

    Biomet initiated this action after complaints were received where OOS AVL Bushing Sets were opened during OSS knee replacement procedures, and were found to contain two tabbed bushings.

    Action

    BIOMET Orthopedics sent an URGENT MEDICAL DEVICE recall notice dated February 7, 2012, to all affected consignees. The recall notice instructed consignees to immediate locate and remove the devices from circulation and to fax back the response form to 574-372-1683. If product was further distributed, consignees must notify hospital personnel of this action via the enclosed notice. Consignees were charged with the location and return of the affected product. For questions regarding this recall call 574-372-3983 or 574-371-3009.

    Distribution

    Worldwide Distribution - USA including IN. KS, NJ, CA, and OH Internationally: The Netherlands

    Quantity

    27 units distributed US and foreign