BEUDAMED
    FDA Recall Terminated

    Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021. Intended to aid in the fabrication of dental prosthetics, and be used as a accessory with endosseous dental implants.

    Recall: Z-2177-2010 · Initiated June 15, 2010

    Recall

    Recall Number
    Z-2177-2010
    Event Number
    56049
    Firm
    Straumann Manufacturing Inc.
    FEI Number
    1000121052
    Product Code
    NDP
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 15, 2010
    Posted
    August 6, 2010
    Terminated
    September 22, 2011
    Address
    60 Minuteman Rd, Andover, MA, 01810

    Description

    Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021. Intended to aid in the fabrication of dental prosthetics, and be used as a accessory with endosseous dental implants.

    Reason

    The label on the tubular packaging for the Straumann Impression set f. WN solid abutment has the incorrect description of RN solid abutment instead of a WN.

    Action

    Field Safety Notice, dated June 15, 2010, issued to consignees states that the 040.380 Impression set f. WN solid abutment Lot Y4021 which you purchased is incorrectly labeled Impression set f. RN solid abutment. Customers were asked to return the affected products and completed Customer Confirmation Form for replacements. Questions should be directed towards Bernard McDonald at 978-747-2514.

    Distribution

    Nationwide Distribution

    Quantity

    163