BEUDAMED
    FDA Enforcement Class II Terminated

    ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.

    Recall: Z-0838-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0838-2018
    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

    ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.

    Reason

    Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.

    Code Info

    Model 0234020280, UDI 07613154643264, Lot No. 17299AG2

    Distribution

    Distributed domestically to . Distributed internationally to Australia and Mexico.

    Quantity

    60,753 units total