BEUDAMED
    FDA Recall Terminated

    Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233. The device is used in orthopedic trauma surgeries for stabilization of tibial bone fractures.

    Recall: Z-1261-2009 · Initiated March 23, 2009

    Recall

    Recall Number
    Z-1261-2009
    Event Number
    51687
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 23, 2009
    Posted
    May 18, 2009
    Terminated
    October 23, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233. The device is used in orthopedic trauma surgeries for stabilization of tibial bone fractures.

    Reason

    The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.

    Action

    Distributors were initially notified by phone on March 23, 2009. Distributors and user accounts were notified by an "Urgent: Device Recall" letter dated March 31, 2009. The letter described the affected product, reason for recall, risks to health, other information and actions for customers. Customers were instructed to quarantine recalled product and to return it to the Zimmer Distribution Center. For questions about the recall, contact Zimmer, Inc. at 1-800-613-6131.

    Distribution

    Worldwide Distribution -- US (states of Florida, Missouri, New Jersey, New York, Ohio, Oklahoma and Texas) and countries of Austria, Japan, Korea and Germany.

    Quantity

    32