BEUDAMED
    FDA Recall Terminated

    Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.

    Recall: Z-0026-04 · Initiated August 21, 2003

    Recall

    Recall Number
    Z-0026-04
    Event Number
    27154
    Firm
    Surgical Specialties Corp
    FEI Number
    2522801
    Product Code
    HNN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 21, 2003
    Posted
    October 15, 2003
    Terminated
    January 13, 2004
    Address
    100 Dennis Drive, Reading, PA, 19606-3776

    Description

    Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.

    Reason

    text on product handle is incorrect

    Action

    The consignees were notified via fax on 8/21/03. One customer received a recall letter via mail on 8/22/03.

    Distribution

    The products were shipped to two hospitals in CA, two sales representatives in NC & IL, and three wholesalers in IL, Belgium, Canada, and Austrailia.

    Quantity

    666 units