BEUDAMED
    FDA Recall Terminated

    Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications. Indications: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis when one or more compartments are involved, 2) correction of varus, valgus, or posttraumatic deformity, 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

    Recall: Z-0533-2013 · Initiated November 15, 2012

    Recall

    Recall Number
    Z-0533-2013
    Event Number
    63781
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    MBV
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 15, 2012
    Posted
    December 17, 2012
    Terminated
    November 8, 2013
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications. Indications: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis when one or more compartments are involved, 2) correction of varus, valgus, or posttraumatic deformity, 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

    Reason

    Biomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver. This could cause a possible delay in surgery greater than 30 minutes, potentially exposing the patient to the increased risks from being under anesthesia for a longer duration.

    Action

    Biomet Recall sent an Urgent Medical Device Recall Notices letter dated November 15, 2012 to distributors, hospital operating room(OR)managers and Surgeons receiving the affected product. The letter identified the affected product, the reason for the recall and actions to be take, including directions to immediately locate and discontinue use of the affected product. Customers were asked to confirm receipt of the notice by calling 1-888-348-9500 extension 1570. Customers with affected product to be returned are asked to obtain RGA # by calling 574-372-6677 or email: [email protected]. A FAX Back Response Form is to be filled out and sent within 3 days of receipt to 574-372-1683. Return product to the Attention of Audrey Daenzer, Field Action Coordinator, Biomet, Attention Return Goods, Building B Recalls, 56 East Bell Drive, Warsaw, IN 46580. Questions related to the notice should be directed to 474-372-3983 or 574-371-3009, Monday- Friday 8 a.m. to 5 p.m.

    Distribution

    Worldwide distribution - USA (nationwide) and the countries of Australia, Canada, Chile, Europe, Japan, Korea, Panama, Puerto Rico and Thailand.

    Quantity

    200