BEUDAMED
    FDA Enforcement Class II Terminated

    STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.

    Recall: Z-0837-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0837-2018
    Event ID
    78668
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 14, 2018
    Initiation Date
    November 17, 2017
    Classification Date
    March 2, 2018
    Termination Date
    January 29, 2024
    Address
    5900 Optical Ct, N/A, San Jose, CA, 95138-1400, United States

    Description

    STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.

    Reason

    Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

    Code Info

    Model 0234010056, UDI 04546540754561, Lot No. 17278AG2

    Distribution

    Distributed domestically to . Distributed internationally to Australia and Mexico.

    Quantity

    60,753 units total