BEUDAMED
    FDA Enforcement Class II Terminated

    Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.

    Recall: Z-0981-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0981-2015
    Event ID
    69767
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Straumann USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2015
    Initiation Date
    October 27, 2014
    Classification Date
    January 15, 2015
    Termination Date
    April 10, 2015
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008, United States

    Description

    Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.

    Reason

    Drill set may contain incorrect drill.

    Code Info

    Lot Numbers: GY037, HA443, HE874, HL216

    Distribution

    Nationwide in the following states: AZ, CA, CO,CT, FL, IA, IL, IN, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OH, OK, OR, PA, RI, TX, VA and WV. Worldwide in the following countries by Institut Straumann AG distribution network: Austria, Australia, Canada, Germany, Spain, Finland, France, United Kingdom, Netherlands, Belgium, Switzerland, Ireland, Italy.

    Quantity

    362 pieces