BEUDAMED
    FDA Recall Terminated

    Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 35 mm, P/N 7211124, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810

    Recall: Z-0608-2008 · Initiated August 21, 2007

    Recall

    Recall Number
    Z-0608-2008
    Event Number
    44704
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 21, 2007
    Posted
    March 19, 2008
    Terminated
    May 9, 2012
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 35 mm, P/N 7211124, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810

    Reason

    Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.

    Action

    Smith & Nephew issued an Urgent Product Recall letter via Federal Express to User Facilities, Sales Reps and Distributors on 8/21/07. A second letter was issued on 8/23/07 to correct two errors in model numbers listed in the original letter. Letter issued by FedEx and/or email to OUS contacts.

    Distribution

    Worldwide Distribution - USA, Austria. Belgium, Germany, Denmark, Spain, Finland, France, England, Italy, Portugal, Netherlands, Norway, New Zealand, Sweden, Turkey, Switzerland, China, Hong Kong, Malaysia, Taiwan, Singapore, Thailand, Australia, Canada, Mexico, Colombia, South Africa, Dubai, Venezuela, and Chile.

    Quantity

    2357 units