BEUDAMED
    FDA Enforcement Class II Terminated

    TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

    Recall: Z-1072-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-1072-2018
    Event ID
    79263
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    October 11, 2017
    Classification Date
    March 15, 2018
    Termination Date
    May 7, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

    Reason

    Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.

    Code Info

    The kits that include the TunneLoc products, ACL in a box, PNs 906532, 906533, 906534, and 906535 are packed in a box alongside the Instructions for use and is distributed non-sterile .

    Distribution

    US Nationwide Distribution