BEUDAMED
    FDA Recall Terminated

    Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, REF 141491. The Biomet Offset Tibial Tray Adaptor is a knee prosthesis intended for cemented use in patients with the following indications: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved, correction of valgus, varus or posttraumatic deformity, correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

    Recall: Z-1061-2009 · Initiated February 13, 2009

    Recall

    Recall Number
    Z-1061-2009
    Event Number
    51136
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JDW
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 13, 2009
    Posted
    April 7, 2009
    Terminated
    August 11, 2009
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, REF 141491. The Biomet Offset Tibial Tray Adaptor is a knee prosthesis intended for cemented use in patients with the following indications: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved, correction of valgus, varus or posttraumatic deformity, correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

    Reason

    A 2.5mm locking insert was packaged with the 5.0mm Offset Tibial Tray Adaptor instead of the 5.0mm locking insert.

    Action

    Consignees were notified by "Field Safety Corrective Action" letter dated February 13, 2009 to conduct a recall to the hospital level and to locate and return the recalled product to Biomet Orthopedics. Customers were also instructed to complete the enclosed "Fax Back Response Form" and return it via fax to Biomet Orthopedics at 1-574-372-1683. Direct questions about this recall to 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

    Worldwide Distribution including Germany, Italy, Netherlands, Spain and the United Kingdom.

    Quantity

    17