BEUDAMED
    FDA Recall Terminated

    Endocoupler , C-Mount 35 mm Focal Length Catalog Number: 7204614, 7204614M, 7204614S

    Recall: Z-0707-04 · Initiated February 19, 2004

    Recall

    Recall Number
    Z-0707-04
    Event Number
    28423
    Firm
    Smith And Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    FXM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 19, 2004
    Posted
    July 20, 2004
    Terminated
    June 28, 2006
    Address
    150 Minuteman Rd, Andover, MA, 01810-1031

    Description

    Endocoupler , C-Mount 35 mm Focal Length Catalog Number: 7204614, 7204614M, 7204614S

    Reason

    Endocouplers assembled with screws that cannot be effectively sterilized

    Action

    Smith & Nephew notified customers and sales rep. by letter dated 2/19/04. Sales reps will retrieve product and replace effected units in the field.

    Distribution

    AL, AZ, CA, CT, PA, MA, ME, MI, MO, NC, NH, NJ, NY, OH, UT , TN, TX, VT, WA Foreiing:Australia, Canada, China, Brazil, France, Germany, Greece, India, Italy, Japan.Korea, Netherlands, Norway, Portugal, South Africa, Spain, Turkey, UK

    Quantity

    102 units