BEUDAMED
    FDA Recall Terminated

    Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm 52-2761, Slit Knife, bevel up, angled, full handled, 2.75mm 52-2861, Slit Knife, bevel up, angled, full handled, 2.85mm 52-2961, Slit Knife, bevel up, angled, full handled, 3.0mm 52-3261, Slit Knife, bevel up, angled, full handled, 3.2mm 52-3561, Slit Knife, bevel up, angled, full handled, 3.5mm 52-2662, Slit Knife, bevel up, angled, blade and tip, 3.2mm 52-3262, Slit Knife, bevel up, angled, blade and tip, 3.2mm

    Recall: Z-0947-04 · Initiated March 3, 2004

    Recall

    Recall Number
    Z-0947-04
    Event Number
    28948
    Firm
    Surgical Specialties Puerto Rico, Inc. Road
    FEI Number
    3008845715
    Product Code
    HNN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 3, 2004
    Posted
    July 20, 2004
    Terminated
    September 10, 2004
    Address
    115 Km.12.9, Rincon, PR, 00677

    Description

    Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm 52-2761, Slit Knife, bevel up, angled, full handled, 2.75mm 52-2861, Slit Knife, bevel up, angled, full handled, 2.85mm 52-2961, Slit Knife, bevel up, angled, full handled, 3.0mm 52-3261, Slit Knife, bevel up, angled, full handled, 3.2mm 52-3561, Slit Knife, bevel up, angled, full handled, 3.5mm 52-2662, Slit Knife, bevel up, angled, blade and tip, 3.2mm 52-3262, Slit Knife, bevel up, angled, blade and tip, 3.2mm

    Reason

    Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.

    Action

    Customers were notified by e-mail and fax of the recall during the period of March 3, 2004 to April 1, 2004. Customers were requested to return the product to Surgical Specialties Corporation, Reading, PA 19606.

    Distribution

    Distribution was nationwide and internationally