BEUDAMED
    FDA Recall Terminated

    Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas

    Recall: Z-1025-04 · Initiated October 2, 2003

    Recall

    Recall Number
    Z-1025-04
    Event Number
    29035
    Firm
    Ascension Orthopedics, Inc
    FEI Number
    3002788818
    Product Code
    NEG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 2, 2003
    Posted
    July 20, 2004
    Terminated
    June 17, 2004
    Address
    8200 Cameron Rd, Ste C-140, Austin, TX, 78754-3832

    Description

    Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas

    Reason

    Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility.

    Action

    Recall was initiated via letter included with replacement trays begining in October 2003.

    Distribution

    Nationwide distrbution to IA, TX, OH, FL, IN, MN, CO, WA, CA, MO, and to a consignee in Ontario, Canada

    Quantity

    107 trays