BEUDAMED
    FDA Recall Terminated

    DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.

    Recall: Z-2731-2011 · Initiated May 6, 2011

    Recall

    Recall Number
    Z-2731-2011
    Event Number
    58733
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    HAB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 6, 2011
    Posted
    July 1, 2011
    Terminated
    May 9, 2012
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.

    Reason

    Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use.

    Action

    Smith & Nephew notified customers by an "URGENT - PRODUCT RECALL 1st NOTIFICATION" letter dated May 6, 2011. The letter describes the product, problem, and actions to be taken. The letter asked customers to call 800-343-5717 (option 3) or send an email to [email protected] for a Return Authorization (RA) Number to return product, obtain credit or order replacement blades. Customers are to complete the form and return to the address provided being sure to reference the RA number. For any questions regarding this recall customers were instructed to call 508-337-3731.

    Distribution

    Worldwide Distribution -- USA (nationwide) and countries of: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong Kong, Italy, Japan, Mexico, Netherlands, Turkey, and United Kingdom.

    Quantity

    744 units