BEUDAMED
    FDA Recall Terminated

    Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm.

    Recall: Z-0705-03 · Initiated January 7, 2003

    Recall

    Recall Number
    Z-0705-03
    Event Number
    25816
    Firm
    Surgical Specialties Corp
    FEI Number
    2522801
    Product Code
    HNN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 7, 2003
    Posted
    April 1, 2003
    Terminated
    March 31, 2003
    Address
    100 Dennis Drive, Reading, PA, 19606-3776

    Description

    Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm.

    Reason

    size mislabeled on product handle

    Action

    On 1/7/03, one account was contacted via telephone. On 1/10/03, a recall letter was faxed to that account. On 3/11/03, this wholesale account was asked to contact a hospital sub account that received a direct shipment. The other account was the complainant and telephone communications were occurring.

    Distribution

    The product was shipped to 2 wholesale accounts in PA and LA.

    Quantity

    635 units