BEUDAMED
    FDA Recall Terminated

    Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERILE

    Recall: Z-1589-2011 · Initiated February 10, 2011

    Recall

    Recall Number
    Z-1589-2011
    Event Number
    57965
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    February 10, 2011
    Posted
    March 7, 2011
    Terminated
    August 27, 2013
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERILE

    Reason

    The cannula could not be connected to the scope and scopes disengage during use. The outer hub of Innervue scopes may become detached from the inner hub of the scopes during assembly of the scope to the Innervue hand piece. This condition may prevent the Innervue scope from being securely attached to the Innervue hand piece.

    Action

    On 2/10/2011, Biomet issued an "URGENT MEDICAL DEVICE NOTICE" to their Direct Accounts instructing customers to identify and discontinue use of the recalled products and return them to Biomet. Response forms were provided.

    Distribution

    Distribution USA nationwide and to the Netherlands

    Quantity

    264