BEUDAMED
    FDA Enforcement Class II Terminated

    Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function

    Recall: Z-0958-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-0958-2017
    Event ID
    75983
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Straumann Manufacturing, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2017
    Initiation Date
    November 23, 2016
    Classification Date
    January 6, 2017
    Termination Date
    August 29, 2019
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008, United States

    Description

    Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function

    Reason

    Drills cannot be inserted into handpiece due to tolerance specification not met

    Code Info

    Lot Number: LV455

    Distribution

    Nationwide Distribution

    Quantity

    120 units