BEUDAMED
    FDA Enforcement Class II Terminated

    Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.

    Recall: Z-1872-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1872-2014
    Event ID
    68405
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Endoscopy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    May 19, 2014
    Classification Date
    June 25, 2014
    Termination Date
    May 7, 2015
    Address
    5900 Optical Ct, N/A, San Jose, CA, 95138-1400, United States

    Description

    Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.

    Reason

    STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.

    Code Info

    Part Number 272-700-000: Lot number: 20476.1 23541 23837 26403 26404 26405 26676 27009 27518 28341 30248 34355 35932 36756 39705 05J034834 06con05774 06CON06360 06CON06846 06con06869 06con06960 06con08587 25067-1-12 26882-1-1 26882-1-11 26882-1-12 26882-1-13 26882-1-14 35200-1-1 36610-1-1 38820-1-1 39078-1-1 40504-2-1 40675-1-1 41231-1-1 41827-1-1 42085-1-1 42375-1-1 42527-1-1 42789-1-1 43103-1-1 43589-1-1 43716-1-1 43716-1-3 43716-1-4 44568-1-10 44568-1-11 44568-1-2 44568-1-3 44568-1-4 44568-1-6 44568-1-7 44568-1-8 44568-1-9 46227-1-1 47731-1-1 48595-1-1 48596-1-1 48597-1-1 48598-1-1 48599-1-1 48600-1-1 50101-1-1 50628-1-1 50828-1-1 51237-1-1 52439-1-1 55035-1-1 55422-1-1 55462-1-1 56456-1-1 R471611 SS15329.

    Distribution

    Worldwide Distribution.

    Quantity

    1992 trays