BEUDAMED
    FDA Recall Terminated

    Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.

    Recall: Z-1244-2014 · Initiated February 26, 2014

    Recall

    Recall Number
    Z-1244-2014
    Event Number
    67618
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    February 26, 2014
    Posted
    March 20, 2014
    Terminated
    July 7, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.

    Reason

    Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.

    Action

    The firm, BIOMET, sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter dated February 26, 2014 via Fed Ex overnight to domestic consignees. Australia and GSCC were notified by email and also received a hard copy letter via mail. The letter described the product, problem and actions to be taken. The letter stated that this action requires the immediate location and discontinued use of the product and its return to Biomet. The Consignees were were instructed to immediately locate, discontinue use of the product and remove the identified device(s) listed; carefully follow the instructions on the FAX Back Response Form and reply within three (3) business days; complete and return Form via Fax to: 574-372-1683 prior to return of product, and use priority carrier for your shipment. If you have further distributed this product, you MUST notify hospital personnel of this action via enclosed "Dear Risk/Recall Manager Notice", and note that you are charged with the location and return of these products. Shipping address is Return Goods, 56 E. Bell Drive Warsaw, IN 46582. Questions related to the notice should be directed to 574-372-1570, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

    Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.

    Quantity

    6