BEUDAMED
    FDA Recall Terminated

    Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument.

    Recall: Z-2445-2008 · Initiated August 6, 2007

    Recall

    Recall Number
    Z-2445-2008
    Event Number
    49122
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 6, 2007
    Posted
    September 20, 2008
    Terminated
    March 11, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument.

    Reason

    Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resulting in surgical delay and an increased risk of infection.

    Action

    Firm's sales representatives were notified via e-mail on 8/6/07 to review their inventory and that of their accounts and to notify the firm of their location so that they could be replaced. Contact the firm by telephone at 574-267-6131 for additional information concerning this recall.

    Distribution

    Nationwide Distribution including states of California, Florida and Washington.

    Quantity

    39