BEUDAMED
    FDA Recall Terminated

    Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.

    Recall: Z-0463-2012 · Initiated November 7, 2011

    Recall

    Recall Number
    Z-0463-2012
    Event Number
    60375
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 7, 2011
    Posted
    January 11, 2012
    Terminated
    February 22, 2016
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.

    Reason

    Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use.

    Action

    Smith & Nephew Inc. Endoscopy Division notified facilities on 11/7/11 via an "Urgent - Product Recall 1st Notification - Urgent" letter and/or phone. The letter identified the affected product and the reason for the recall. It also discussed the potential risks, customer actions, and instructions for the return of the product. Customers were to check their inventory and locate any of the affected product. They were to also complete the requested contact information and return the notification letter. In addition, customers were to contact Smith & Nephew Endoscopy Division Returns Group at [email protected] for information on how to return the affected product and receive replacement product. Questions, contact Hoangthi Le directly by phone at 508-337-3731.

    Distribution

    Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Dubai, Finland, France, Germany, Norway, South Africa, Switzerland, United Kingdom, and Venezuela.

    Quantity

    1743 units