BEUDAMED
    FDA Recall Terminated

    Reamer T-Handle; Non- Sterile; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. Intended for use in orthopaedic surgery to interface with various cutting instruments and drivers.

    Recall: Z-0793-2010 · Initiated August 8, 2005

    Recall

    Recall Number
    Z-0793-2010
    Event Number
    50099
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HTO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 8, 2005
    Posted
    February 17, 2010
    Terminated
    February 18, 2010
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    Reamer T-Handle; Non- Sterile; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. Intended for use in orthopaedic surgery to interface with various cutting instruments and drivers.

    Reason

    Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.

    Action

    Stryker Orthopaedics issued notification dated August 8, 2005 via Federal Express. Consignees were informed of the affected product and necessary steps to take for product replacement. For further information, contact Stryker at (201) 831-5825.

    Distribution

    Worldwide Distribution -- United States, Germany, The Netherlands, Spain, Italy, Switzerland, Poland, Romania, South Africa, England, Columbia, Venezuela, Japan and Australia.

    Quantity

    273