BEUDAMED
    FDA Enforcement Class II Terminated

    Black Mamba Suture Passer

    Recall: Z-0471-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0471-2016
    Event ID
    72829
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2015
    Initiation Date
    December 2, 2015
    Classification Date
    December 23, 2015
    Termination Date
    October 27, 2016
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Black Mamba Suture Passer

    Reason

    There may be a separation and an insufficient weld between the spring and washer. The weld between the spring and washer may fracture, causing the Mamba Suture Passer instruments jaw to not actuate properly. 6 complaints have been received in which 3 have been reported with a delay up to 10 minutes.

    Code Info

    Catalog Number: 110010849 Lot Number Identification: 167880, 169620, 253190, 520810, 538490, 551550, 716270, 960180

    Distribution

    FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI

    Quantity

    50