BEUDAMED
    FDA Recall Terminated

    Neos Vanadium Excavator Part Number 591/5 SCHE

    Recall: Z-0158-2010 · Initiated November 14, 2008

    Recall

    Recall Number
    Z-0158-2010
    Event Number
    50763
    Firm
    Sybron Dental Specialties
    FEI Number
    2024312
    Product Code
    EKC
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    November 14, 2008
    Posted
    November 9, 2009
    Terminated
    August 9, 2012
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    Neos Vanadium Excavator Part Number 591/5 SCHE

    Reason

    The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.

    Action

    Sybron Dental wrote to the distributor by letter dated November 20, 2008 and posted Nov 24, 2008 titled "URGENT MEDICAL DEVICE RECALL," informing them of the recall, and the reason for recall. Sybron informed the distributor to return affected batches of product. Any product in stock with the mentioned batch number was replaced at no charge or credited to their account. The consignee was also asked to contact KerrHawe Customer Care at +41 91 610 05 05 to receive an RGA number. The affected product should be returned to KerrHawe at the following address: KerrHawe SA Via Strecce 4 CH-6934 Bioggio Switzerland PLEASE LABEL RETURNED PRODUCT "RECALLED PRODUCT RETURN". In addition, they asked for the completed RETURN FORM to be returned by fax to +41 91 610 05 14

    Distribution

    Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.

    Quantity

    10