BEUDAMED
    FDA Recall Terminated

    Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000.

    Recall: Z-0171-04 · Initiated November 12, 2003

    Recall

    Recall Number
    Z-0171-04
    Event Number
    27690
    Firm
    Stryker Instruments, Instruments Div.
    FEI Number
    1811755
    Product Code
    FPK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 12, 2003
    Posted
    July 20, 2004
    Terminated
    May 3, 2004
    Address
    4100 E. Milham, Kalamazoo, MI, 49001

    Description

    Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000.

    Reason

    Product sterility may have been compromised by an inadequate package seal.

    Action

    Recall letters dated 11/12/03 were issued to each customer and sales representatives were requested to question each account about affected product.

    Distribution

    United States, France and United Kingdom.

    Quantity

    15