BEUDAMED
    FDA Recall Terminated

    Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578. Product is intended to be used during the interdental osteotomy (bone cutting).

    Recall: Z-1871-2008 · Initiated April 16, 2008

    Recall

    Recall Number
    Z-1871-2008
    Event Number
    48458
    Firm
    Biomet Microfixation, Inc.
    FEI Number
    1032347
    Product Code
    EMM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 16, 2008
    Posted
    September 11, 2008
    Terminated
    September 11, 2009
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480

    Description

    Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578. Product is intended to be used during the interdental osteotomy (bone cutting).

    Reason

    The working tips of the Stella Osteotomes are thicker than specification.

    Action

    The firm notified its consignees on 4/16/08 by certified mail with return receipt. Sub-accounts were contacted by email. All returned product will be stored in quarantine until a final determination of disposition is made.

    Distribution

    Distributed domestically to Missouri, New Mexico and Texas, and countries of Canada and Germany.

    Quantity

    36