BEUDAMED
    FDA Recall Terminated

    BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL

    Recall: Z-1366-2008 · Initiated February 14, 2008

    Recall

    Recall Number
    Z-1366-2008
    Event Number
    47342
    Firm
    Biomet 3i, Inc.
    FEI Number
    1038806
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 14, 2008
    Posted
    March 29, 2008
    Terminated
    July 10, 2008
    Address
    4555 Riverside Drive, Palm Beach Gardens, FL, 33410

    Description

    BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL

    Reason

    Mis-labeling: Labeled THA53 device packaging may contain ITHA53 devices (The ITHA53 is designed to be used with an internally hexed implant--The THA53 is used with an external hex platform)

    Action

    Each USA customer was first contacted by telephone and then with a faxed, Urgent Medical Device Recall letter, dated 2/25/2008. Each International customer was first contacted by E-mail and then with a faxed letter. They were instructed to return the affected product to Biomet 3i.

    Distribution

    Worldwide

    Quantity

    254