BEUDAMED
    FDA Recall Terminated

    BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP STAINLESS STEEL, NON-STERILE, BIOMET MICROFIXATION, INC. 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA.

    Recall: Z-1949-2009 · Initiated February 16, 2009

    Recall

    Recall Number
    Z-1949-2009
    Event Number
    52672
    Firm
    Biomet Microfixation, Inc.
    FEI Number
    1032347
    Product Code
    EJL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 16, 2009
    Posted
    September 8, 2009
    Terminated
    November 5, 2009
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480

    Description

    BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP STAINLESS STEEL, NON-STERILE, BIOMET MICROFIXATION, INC. 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA.

    Reason

    Biomet Microfixation is recalling the 46-1004, Trauma One Drill, 18.x115 mm, 26 mm Stop Lot Numbers 619450 and JC1002. The drills may be color-banded blue instead of brown. The color is a visual aid in determining what system the drill goes with. The blue indicates the drill is for the 2.0mm system. The brown indicates the drill is to be used for our 2.3mm system. The drill is etched and labe

    Action

    Biomet Microfixation, Inc. issued an Urgent Medical Device Recall Notice dated February 19, 2009 via certified mail with return receipt. The notice informed users of the affected device and instructed them to immediately discontinue use and return to the firm. Consignees were also instructed to complete and return an Inventory Reconciliation sheet via fax to 1-904-741-9425. For further information, contact Biomet Microfixation, Inc. at 1-800-874-7711 or 1-904-741-4400.

    Distribution

    Nationwide Distribution -- Texas, Maryland, Florida, Washington DC, Michigan, Kansas Colorado and Missouri.

    Quantity

    79