BEUDAMED
    FDA Recall Terminated

    T2 Recon Nail System.

    Recall: Z-0060-06 · Initiated August 12, 2005

    Recall

    Recall Number
    Z-0060-06
    Event Number
    33196
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 12, 2005
    Posted
    October 15, 2005
    Terminated
    July 20, 2006
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    T2 Recon Nail System.

    Reason

    The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility.

    Action

    The notification letters and product accountability forms were sent via FedEx on 8/12/2005 with return receipt.

    Distribution

    The devices have been distributed to Stryker Branches/Agencies, Hospitals nationwide, and Government hospitals. There are no international customers.

    Quantity

    4698 PIECES