BEUDAMED
    FDA Recall Terminated

    BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***. Bone screws used along with implantable bone plates for oral, cranio-maxillofacial procedures.

    Recall: Z-1943-2010 · Initiated October 5, 2009

    Recall

    Recall Number
    Z-1943-2010
    Event Number
    54366
    Firm
    Biomet Microfixation, Inc.
    FEI Number
    1032347
    Product Code
    JEY
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    October 5, 2009
    Posted
    June 30, 2010
    Terminated
    December 15, 2010
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480

    Description

    BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***. Bone screws used along with implantable bone plates for oral, cranio-maxillofacial procedures.

    Reason

    Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.

    Action

    Biomet Microfixation notified each consignee by email and fax on 10/05/2009. Each consignee was asked to use the included Response Form to provide product disposition.

    Distribution

    US distribution: CA, CO, MI, and MO.

    Quantity

    91 units