BEUDAMED
    FDA Recall Terminated

    BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT. Part Number SP-1918 BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA.

    Recall: Z-1319-2010 · Initiated January 15, 2010

    Recall

    Recall Number
    Z-1319-2010
    Event Number
    54375
    Firm
    Biomet Microfixation, Inc.
    FEI Number
    1032347
    Product Code
    HWR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 15, 2010
    Posted
    April 11, 2010
    Terminated
    May 14, 2010
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480

    Description

    BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT. Part Number SP-1918 BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA.

    Reason

    The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction device as intended. If the distraction device does not advance, bone consolidation may occur and a second surgery may be necessary.

    Action

    Consignees will be notified by letter on 01/15/2010 be either fax, email or mail.

    Distribution

    US ( AZ,CA,DC,FL,GA,ID,IL,IN,MO,NC,TX,UT), Japan, Finland, Africa

    Quantity

    73