BEUDAMED
    FDA Recall Terminated

    TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.

    Recall: Z-0577-2008 · Initiated November 23, 2007

    Recall

    Recall Number
    Z-0577-2008
    Event Number
    46158
    Firm
    Tenet Medical Engineering Inc 11979 40th St Se /#203 Ab Calgary Canada
    FEI Number
    3004750931
    Product Code
    JEB
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 23, 2007
    Posted
    February 26, 2008
    Terminated
    May 1, 2009

    Description

    TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.

    Reason

    Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.

    Action

    TENET notified US distributor consignee via Urgent Product Recall Notification letter sent FedEx on 11/23/07. Consignee asked to return product and to contact their consignees to also return product.

    Distribution

    Nationwide Distribution.

    Quantity

    300 units.