BEUDAMED
    FDA Recall Terminated

    Smith & Nephew Suture Passer 12 inch Part Number 7209166D (refurbished)

    Recall: Z-0725-2007 · Initiated March 1, 2007

    Recall

    Recall Number
    Z-0725-2007
    Event Number
    37582
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 1, 2007
    Posted
    April 7, 2007
    Terminated
    July 14, 2008
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    Smith & Nephew Suture Passer 12 inch Part Number 7209166D (refurbished)

    Reason

    Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use.

    Action

    Smith & Nephew notified accounts by letter on 3/1/07, users are advised to destroy product and return unused product in their inventory. A reply form is required to be completed.

    Distribution

    World wide- USA and Canada, Belgium. Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Italy, Netherlands, Portugal, Austria, Ireland, Sweden, Argentina. Chile, Columbia, Brazil, China. Japan, Korea, Thailand, Hong Kong, Malaysia. Taiwan, Singapore, India, , Dubai, Mexico, Australia, Egypt. Switzerland, New Zealand and Norway

    Quantity

    12, 292 units for all recalls Z-0724-0726-07