BEUDAMED
    FDA Recall Terminated

    Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Number: 013554 Orthopedic Manual Surgical Instrument

    Recall: Z-3050-2011 · Initiated July 7, 2011

    Recall

    Recall Number
    Z-3050-2011
    Event Number
    59329
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 7, 2011
    Posted
    August 22, 2011
    Terminated
    July 23, 2015
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Number: 013554 Orthopedic Manual Surgical Instrument

    Reason

    Shaft tip (casting) does not meet the SNE 416 specification, which could result in rusting of the Tendon Strippers

    Action

    Smith & Nephew sent an Urgent - Product Recall Notification letter dated July 7, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the form included in the letter and return to [email protected] or fax to 508-261-3620. Each affiliate must then notify each facility affected by the recall. To return product and obtain credit or order replacement product customers should contact the Smith & Nephew Endoscopy Returns at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to, [email protected]. For questions, contact Hoangthi by phone at 508-337-3731.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark, Dubai, Finland, France, Germany, Greece, Hong Kong, India, Italy, Israel, Japan, Korea, Malaysia, Mexico, Netherland, Norway, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, and Venezuela

    Quantity

    570 units