BEUDAMED
    FDA Recall Terminated

    Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA

    Recall: Z-2242-2014 · Initiated July 1, 2014

    Recall

    Recall Number
    Z-2242-2014
    Event Number
    68931
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    July 1, 2014
    Posted
    August 15, 2014
    Terminated
    October 30, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA

    Reason

    The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.

    Action

    Urgent Medical Device Recall Notices dated July 15, 2014 were mailed with verification of delivery via FedEx. Response forms were provided to all consignees in order for Biomet to track returns. The letters informed the consignees to return the devices to Biomet and conduct a sub-recall sending the recall letter to all customers.

    Distribution

    California, IA, FL, MD, UT, SC, AL, IL, CO, MA, KS, GA, WA, NV, AR, NH, OK,Pennsylvania, New York, Texas, Virginia, New Jersey, North Carolina, Kentucky, Michigan, Ohio, Wisconsin, Louisiana, Arizona, Indiana, South Dakota, Missouri & Montana. In addition to Korea, B.V., Japan, Puerto Rico, UK, Chile, New Zealand, Australia, & Canada

    Quantity

    461