BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2465-2015 · Initiated August 6, 2015

    Recall

    Recall Number
    Z-2465-2015
    Event Number
    71913
    Firm
    Tornier, Inc
    FEI Number
    3000718467
    Product Code
    HSN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 6, 2015
    Posted
    August 26, 2015
    Terminated
    April 8, 2016
    Address
    10801 Nesbitt Ave S, Bloomington, MN, 55437-3109

    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.

    Action

    Distributors were sent on 8/6/2015 a Tornier "Urgent - Medical Device Recall" letter, dated August 5, 2015. The letter described the problem and the product involved in the recall. Consignees were advised to review their inventory and the inventory of all reps within their area for the recalled device. The letter requested that consignees complete and return the questionnaire to [email protected]. A Tornier representative will organize the collection and replacement of the devices. For questions they can contact Customer Service Department at 1 (888) 494-7950.

    Distribution

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

    Quantity

    5