BEUDAMED
    FDA Recall 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 · Initiated October 27, 2014

    Recall

    Recall Number
    Z-0981-2015
    Event Number
    69767
    Firm
    Straumann USA, LLC
    FEI Number
    1000121052
    Product Code
    NDP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 27, 2014
    Posted
    January 15, 2015
    Terminated
    April 10, 2015
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    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.

    Action

    Straumann sent a Field Safety Corrective Action by letter dated October 29, 2014 which was delivered via United Parcel Service. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to examine their inventory and return the product. In addition, customers are asked to complete a Customer Confirmation Form and return it to Straumann via fax to (978)747-0023.

    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