Events

Recall of Device Recall Impression Set, dental

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

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
    56049
  • Event Risk Class
    Class 3
  • Event Number
    Z-2177-2010
  • Event Initiated Date
    2010-06-15
  • Event Date Posted
    2010-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92526
  • 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
    Endosseous Dental Implant Accessories. - Product Code NDP
  • Reason
    The label on the tubular packaging for the straumann impression set f. wn solid abutment has the incorrect description of rn solid abutment instead of a wn.
  • Action
    Field Safety Notice, dated June 15, 2010, issued to consignees states that the 040.380 Impression set f. WN solid abutment Lot Y4021 which you purchased is incorrectly labeled Impression set f. RN solid abutment. Customers were asked to return the affected products and completed Customer Confirmation Form for replacements. Questions should be directed towards Bernard McDonald at 978-747-2514.

Device

Device Recall Impression Set, dental
  • Model / Serial
    Lot # Y4021
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021. || Intended to aid in the fabrication of dental prosthetics, and be used as a accessory with endosseous dental implants.
  • Manufacturer
    Straumann Manufacturing Inc.

Manufacturer

Straumann Manufacturing Inc.
  • Manufacturer Address
    Straumann Manufacturing Inc., 60 Minuteman Rd, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Straumann Holding AG
  • Source
    USFDA