BEUDAMED
    FDA Recall Terminated

    The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.

    Recall: Z-1744-2015 · Initiated May 14, 2015

    Recall

    Recall Number
    Z-1744-2015
    Event Number
    71365
    Firm
    BIOMET FRANCE S.A.R.L. plateau de lautagne valence cedex
    FEI Number
    3006946279
    Product Code
    KIH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 14, 2015
    Posted
    June 10, 2015
    Terminated
    October 27, 2015
    Address
    9 Valence Cedex 9 France

    Description

    The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.

    Reason

    The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.

    Action

    BIOMET sent an URGENT ADVISORY NOTICE dated May 14, 2015, to all affected customers via courier. 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. Customers were instructed to check the product to identify to determine if the pin is defective, if defective they should return it to Biomet Warsaw, following the directions on the Response Form and confirm receipt of the notice by sending back the response form. Questions related to this notice should be directed to (574) 372- 1570 Monday through Friday 8 a.m. to 5 p.m.

    Distribution

    Nationwide distribution to MD only

    Quantity

    3