BEUDAMED
    FDA Recall Terminated

    Arthrex Reciprocating Saw Attachment Type: V-600SR Distributed by: Arthrex Inc., Naples, Florida United States The system Is a modular electric system, consisting of a handpiece drive, various accessories, and a charging station for machining bones. It can be used in the following areas of application: orthopaedic and A&E Interventions, such as osteotomies, large and small bone operations, and joint replacement operations. The charging station is intended exclusively for charging V 600 Li-Ion and V 300 LiIon rechargeable batteries

    Recall: Z-2879-2011 · Initiated May 24, 2011

    Recall

    Recall Number
    Z-2879-2011
    Event Number
    59146
    Firm
    W & H DentalWerk Buermoos GMBH 53 Ignaz-Glazer-Strasse Burmoos Austria
    FEI Number
    3003755849
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    May 24, 2011
    Posted
    July 25, 2011
    Terminated
    October 9, 2015

    Description

    Arthrex Reciprocating Saw Attachment Type: V-600SR Distributed by: Arthrex Inc., Naples, Florida United States The system Is a modular electric system, consisting of a handpiece drive, various accessories, and a charging station for machining bones. It can be used in the following areas of application: orthopaedic and A&E Interventions, such as osteotomies, large and small bone operations, and joint replacement operations. The charging station is intended exclusively for charging V 600 Li-Ion and V 300 LiIon rechargeable batteries

    Reason

    Reciprocating saw attachment V 600 Sr (REF: 17306210), screws can become loose or come off (the attachment) and fall into the surgical wound and may not be noticed due to its small size.

    Action

    Madrimed GmbH (Distributor partner) of W&H Dentalmechanik GmbH sent a letter dated May 24, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were ask to advise their users to check the adapters thoroughly before and after each application, until the conversion of all attachments have been completed and to send all products that need to be converted to the nearest service centers. W&H decided to convert all products that might be affected in their service centres and equip them with an additional security device. If you have any questions, call +43627462360 or email: [email protected].

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Austia, Australia, Canada, Czech Republic, Denmark, France, Germany, Italy, Kuwait, Malaysia, Netherlands, Russia, Slovakia, South Africa, Spain, Taiwan, Turkey and United Kingdom.

    Quantity

    194 units