BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2315-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2315-2015
    Event ID
    71605
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tornier, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2015
    Initiation Date
    June 25, 2015
    Classification Date
    July 29, 2015
    Termination Date
    August 31, 2017
    Address
    10801 Nesbitt Ave S, N/A, Bloomington, MN, 55437-3109, United States

    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.

    Code Info

    Lots: DB0114069, DB0114349, CA46096, CA216052, DB0111264001, DB0112016, DB0113102.

    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