BEUDAMED
    FDA Recall Terminated

    Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical templates for the initial placement of the 2.2 mm pilot drill used in the site preparation for the placement of Straumann dental implants.

    Recall: Z-1876-2008 · Initiated May 28, 2008

    Recall

    Recall Number
    Z-1876-2008
    Event Number
    48610
    Firm
    Straumann Manufacturing Inc.
    FEI Number
    1000121052
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 28, 2008
    Posted
    September 16, 2008
    Terminated
    November 6, 2009
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    Description

    Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical templates for the initial placement of the 2.2 mm pilot drill used in the site preparation for the placement of Straumann dental implants.

    Reason

    Handpiece driver is out of specification and will not function with the dental solid abutment. Possible risks involved include: inconvenience to patient and the need to reschedule surgery or proceed without the device.

    Action

    On May 28, 2008, Straumann issued an Urgent Device Recall and a Recall Acknowledgement Form to its consignees via Fed Ex. Accounts are requested to return product and a replacement or credit will issue. If you have any questions contact Bernie McDonald at (978) 747-2514.

    Distribution

    Class III Recall - Nationwide Distribution.

    Quantity

    129 units