BEUDAMED
    FDA Recall Terminated

    Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.

    Recall: Z-2204-2010 · Initiated April 20, 2010

    Recall

    Recall Number
    Z-2204-2010
    Event Number
    55909
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 20, 2010
    Posted
    August 10, 2010
    Terminated
    January 19, 2011
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.

    Reason

    A knee implant labeled as left was opened and the package actually contained a right knee implant.

    Action

    On 4/13, 14 and 15 Biomet made phone calls to the consignees to inform them of the recall. The firm sent Urgent Medical Device Recall Notices dated 4/20/2010. The customers were instructed to immediately locate the recalled products and return them to the manufacturer.

    Distribution

    1 unit in US. 3 units in Biomet distributor inventory, 1 unit in Japan

    Quantity

    5