BEUDAMED
    FDA Recall Terminated

    Exact Calcar Planer Rasp Style Blade, 42mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473796. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.

    Recall: Z-2371-2008 · Initiated July 18, 2008

    Recall

    Recall Number
    Z-2371-2008
    Event Number
    49013
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    GFA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 18, 2008
    Posted
    September 29, 2008
    Terminated
    June 26, 2009
    Address
    56 E Bell Dr, Warsaw, IN, 46581-0587

    Description

    Exact Calcar Planer Rasp Style Blade, 42mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473796. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.

    Reason

    The blades will oxidize after the first cleaning.

    Action

    Distributors were notified via letter dated 7/18/08 to locate and remove the products and to return them. Distributors were instructed to conduct the recall to the hospital level and to notify the hospitals of the recall by copy of an undated recall letter. Contact Biomet, Inc. at 1-800-348-9500, ext. 3983 for assistance.

    Distribution

    Nationwide and China.

    Quantity

    141 of all products