BEUDAMED
    FDA Enforcement Class II Terminated

    Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument

    Recall: Z-2465-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2465-2015
    Event ID
    71913
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tornier, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2015
    Initiation Date
    August 6, 2015
    Classification Date
    August 26, 2015
    Termination Date
    April 8, 2016
    Address
    10801 Nesbitt Ave S, N/A, Bloomington, MN, 55437-3109, United States

    Description

    Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument

    Reason

    Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility the time of putting the Talar pin in the guide.

    Code Info

    Lot #14F005

    Distribution

    Distributed to CA, ME, NC, PA, and TX.

    Quantity

    5