BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1872-2014 · Initiated May 19, 2014

    Recall

    Recall Number
    Z-1872-2014
    Event Number
    68405
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 19, 2014
    Posted
    June 25, 2014
    Terminated
    May 7, 2015
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    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.

    Action

    Device Correction letters were sent on May 23, 2014 to all users by certified mail. Internation sites will receive notification and be responsible for contacting customers.

    Distribution

    Worldwide Distribution.

    Quantity

    1992 trays