BEUDAMED
    FDA Recall Terminated

    2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG. (2.) QTY 00001, CE 0086, *** NON-STERILE PRODUCT***, 1.0 MM TITANIUM, BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, www.biometmicrofixation.com. (3.) #01-9205, LOT 999999, QTY 00001, 4 HOLE PLATE, STRAIGHT, LONG, 1.0 MM, CE 0086

    Recall: Z-0108-2011 · Initiated August 31, 2010

    Recall

    Recall Number
    Z-0108-2011
    Event Number
    56802
    Firm
    Biomet Microfixation, Inc.
    FEI Number
    1032347
    Product Code
    JEY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 31, 2010
    Posted
    October 20, 2010
    Terminated
    November 19, 2010
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480

    Description

    2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG. (2.) QTY 00001, CE 0086, *** NON-STERILE PRODUCT***, 1.0 MM TITANIUM, BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, www.biometmicrofixation.com. (3.) #01-9205, LOT 999999, QTY 00001, 4 HOLE PLATE, STRAIGHT, LONG, 1.0 MM, CE 0086

    Reason

    Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package contains a 01-9204 (2.0/1.0 4 Hole Regular Plate).

    Action

    Biomet Microfixation sent URGENT MEDICAL DEVICE RECALL NOTICES dated August 31, 2010 to its customers and distributors, identifying the affected product and actions to be taken by customers. Customers were requested to check their inventory for product and return any affected product to Biomet Microfixation. Customer questions or concerns should be directed to Laura Sabo, VP Global QA/RA at 904-741-4500.

    Distribution

    Worldwide Distribution: USA including states of Hawaii and Kansas, and the countries of Australia, Denmark, Italy, Jordan, and South Africa.

    Quantity

    56