BEUDAMED
    FDA Recall 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 · Initiated November 23, 2016

    Recall

    Recall Number
    Z-0958-2017
    Event Number
    75983
    Firm
    Straumann Manufacturing, Inc.
    FEI Number
    1000121052
    Product Code
    NDP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 23, 2016
    Terminated
    August 29, 2019
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    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

    Action

    Straumann sent an Urgent Field Safety Notice to all affected customers via UPS on November 23, 2016 for next day delivery. Customers were requested to check inventory for the listed article and lot numbers and return all unused, packaged parts. Replacement drills will be sent upon receipt. Complete the Confirmation Form and fax the form to the number listed on the form. For questions regarding this recall call 800-448-8168.

    Distribution

    Nationwide Distribution

    Quantity

    120 units