BEUDAMED
    FDA Enforcement Class II Terminated

    Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.

    Recall: Z-1734-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1734-2018
    Event ID
    79682
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 16, 2018
    Initiation Date
    March 28, 2018
    Classification Date
    May 8, 2018
    Termination Date
    March 29, 2019
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.

    Reason

    Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.

    Code Info

    lot 207910

    Distribution

    Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.

    Quantity

    54