Events

Recall of Device Recall Straumann

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
    32354
  • Event Risk Class
    Class 2
  • Event Number
    Z-0975-05
  • Event Initiated Date
    2005-06-06
  • Event Date Posted
    2005-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39853
  • 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
    Implant, Endosseous, Root-Form - Product Code DZE
  • Reason
    Basal screw is too short to adequately hold the dental abutment in the implant.
  • Action
    Straumann USA initiated the recall by letter dated 6/6/05. Users are requested to return devices and to examine patients with the implanted device.

Device

Device Recall Straumann
  • Model / Serial
    Lot Number: 1007
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AZ, CA, DE, FL, NY, OH, OK, TX
  • Product Description
    RN synOcta Meso Abutment, crown margin 8.0mm, Ti || Article: 048.560
  • Manufacturer
    Straumann Manufacturing Inc

Manufacturer

Straumann Manufacturing Inc
  • Manufacturer Address
    Straumann Manufacturing Inc, 60 Minuteman Rd, Andover MA 01810
  • Source
    USFDA