BEUDAMED
    FDA Enforcement Class II Terminated

    Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.

    Recall: Z-0056-2015 · Reported October 15, 2014

    Enforcement

    Recall Number
    Z-0056-2015
    Event ID
    69360
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 15, 2014
    Initiation Date
    September 26, 2014
    Classification Date
    October 9, 2014
    Termination Date
    July 14, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46581, United States

    Description

    Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.

    Reason

    An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.

    Code Info

    Catalog Number: 110010849 Lot Number: 169620, 253190

    Distribution

    Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.

    Quantity

    15 units