BEUDAMED
    FDA Recall Terminated

    Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number: 006689-903

    Recall: Z-0615-2007 · Initiated February 19, 2007

    Recall

    Recall Number
    Z-0615-2007
    Event Number
    37404
    Firm
    Gyrus ACMI Corporation
    FEI Number
    3003790304
    Product Code
    KNS
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 19, 2007
    Posted
    March 13, 2007
    Terminated
    February 24, 2008
    Address
    136 Turnpike Rd, Southborough, MA, 01772-2118

    Description

    Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number: 006689-903

    Reason

    Product sterility may be compromised due to failure of the tray seal packaging

    Action

    Gyrus ACMi issued recall letters on 2/19/07. Each account is asked to remove recalled product and return product .

    Distribution

    Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.

    Quantity

    11 boxes (5 units/box)