Events

Recall of straumann

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Straumann USA, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69767
  • Event Risk Class
    Class 2
  • Event Number
    Z-0981-2015
  • Event Initiated Date
    2014-10-27
  • Event Date Posted
    2015-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131491
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accessories, implant, dental, endosseous - Product Code NDP
  • 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.

Device

straumann
  • Model / Serial
    Lot Numbers: GY037, HA443, HE874, HL216
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
  • Manufacturer
    Straumann USA, LLC

Manufacturer

Straumann USA, LLC
  • Manufacturer Address
    Straumann USA, LLC, 60 Minuteman Rd, Andover MA 01810-1008
  • Manufacturer Parent Company (2017)
    Straumann Holding AG
  • Source
    USFDA