BEUDAMED
    FDA Recall Terminated

    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.

    Recall: Z-2315-2015 · Initiated June 25, 2015

    Recall

    Recall Number
    Z-2315-2015
    Event Number
    71605
    Firm
    Tornier, Inc
    FEI Number
    3000718467
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 25, 2015
    Posted
    July 29, 2015
    Terminated
    August 31, 2017
    Address
    10801 Nesbitt Ave S, Bloomington, MN, 55437-3109

    Description

    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.

    Reason

    Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports that the mast of the targeting jig (Part Number 9020060) is separating from the jig boom. Separation will impact alignment and can affect the ability to fixate Aequalis IM Nail screws.

    Action

    Consignees were sent on 6/25/2015 a Tornier "Urgent Medical Device Recall" letter dated June 24, 2015. The letter described the problem and the product affected by the recall. The letter provided information on jig inspection and referred consignee to the attached "Perfect Circles' surgical technique that should be used when separation is observed. Requested consignees to complete and return the questionnaire to [email protected]. For questions they can contact Customer Service Department at 1(888)494-7950.

    Distribution

    US: AL, AK, AZ, CA, CO, CT, FL, IL, IN, ME, MD, MI, MO, NC, OH, PA, TX. OUS: CANADA AND FRANCE.

    Quantity

    99