BEUDAMED
    FDA Recall Terminated

    BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL.

    Recall: Z-1363-2008 · Initiated February 7, 2008

    Recall

    Recall Number
    Z-1363-2008
    Event Number
    47340
    Firm
    Biomet 3i, Inc.
    FEI Number
    1038806
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 7, 2008
    Terminated
    July 10, 2008
    Address
    4555 Riverside Drive, Palm Beach Gardens, FL, 33410

    Description

    BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL.

    Reason

    Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and visa versa

    Action

    Each USA customer was contacted by telephone and then by letter, Urgent Medical Device Recall, dated 2/15/2008, sent by fax. International customers were first contacted by E-mail then by fax letter also. Each customer was instructed to check their respective inventory for the affected part and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory for product return. They were also instructed to return the affected product to Biomet 3i.

    Distribution

    Worldwide.

    Quantity

    100