BEUDAMED
    FDA Recall Terminated

    Black Mamba Suture Passer

    Recall: Z-0471-2016 · Initiated December 2, 2015

    Recall

    Recall Number
    Z-0471-2016
    Event Number
    72829
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HWQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 2, 2015
    Terminated
    October 27, 2016
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    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.

    Action

    On 12/2/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors and hospital risk managers via courier with instructions to locate and return the affected products. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

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

    Quantity

    50