BEUDAMED
    FDA Enforcement Class II Terminated

    TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.

    Recall: Z-0753-2013 · Reported February 6, 2013

    Enforcement

    Recall Number
    Z-0753-2013
    Event ID
    64004
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2013
    Initiation Date
    January 3, 2013
    Classification Date
    January 30, 2013
    Termination Date
    August 2, 2013
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.

    Reason

    Thru hole at the tip of the screw is undersized.

    Code Info

    Catalog Number: 909668 Lot Number Identification: 716710

    Distribution

    Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.

    Quantity

    44 units distributed