BEUDAMED
    FDA Recall Terminated

    Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

    Recall: Z-0044-2011 · Initiated April 29, 2010

    Recall

    Recall Number
    Z-0044-2011
    Event Number
    55602
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    NBH
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 29, 2010
    Posted
    October 12, 2010
    Terminated
    May 9, 2012
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

    Reason

    Endofemoral Aimer tip may separate due to failure of the soldered joint

    Action

    Smith & Nephew sent a "Medical Device Recall Information" letter dated April 29, 2010, with an attached "Urgent-Product Recall 1st Notification - Urgent" response form via Federal Express on April 29, 2010, to all customers. An e-mail was sent to the contacts in the identified OUS countries alerting them of the recall. ( Note: On June 24, 2010, the firm expanded the recall to include 4 additional catalog numbers 7220l713F, 72201714F, 72201715F, 722017l6F that are refurbished and one additional lot number to catalog Number: 72201714.) The letter described the product, problem and action to be taken by customers. The customers were instructed to immediately check stock for affected product; immediately remove the items from stock and set aside for quarantine; complete and return the attached Urgent-Product Recall 1st Notification - Urgent" response form, even if no product is being returned, via fax at +1-508-261-3636 attention Cindy Burns or email a PDF to [email protected]; call for a return Authorization number at 1-800-343-5717 Option #3, and return product to Smith & Nephew, Inc., Endoscopy Division as soon as possible. If you have any questions or require additional information, please contact Cindy Burns at 1-508-261-3655.

    Distribution

    Worldwide distribution: USA and countries including: Australia, Austria, Belgium, Brazil, Canada, Costa Rica, Denmark. Dubal, Finland, France. Germany, Greece, Hong Kong, India, Italy, Japan, Malaysia, Netherlands. Norway, Portugal, Puer To Rico, Singapore. South Africa, Spain. Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.

    Quantity

    704 units