BEUDAMED
    FDA Recall Terminated

    Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.

    Recall: Z-0555-2010 · Initiated February 26, 2009

    Recall

    Recall Number
    Z-0555-2010
    Event Number
    51219
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    HSX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 26, 2009
    Posted
    December 22, 2009
    Terminated
    February 28, 2011
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.

    Reason

    Smaller diameter screws than required were included in the package.

    Action

    Zimmer notified consignees by recall letter dated 2/25/09 instructing them to cease use of the device and to return it. Zimmer distributors and international accounts were notified by email on 2/26/09.

    Distribution

    USA (Connecticut, Indiana, Pennsylvania), Australia, Serbia, Spain, Switzerland and the United Kingdom.

    Quantity

    13