Events

Recall of Straumann coDiagnostiX

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
    56994
  • Event Risk Class
    Class 2
  • Event Number
    Z-1592-2011
  • Event Date Posted
    2011-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95137
  • 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
    dental implant planning system - Product Code LLZ
  • Reason
    Software: surgical error may occur when the implant length is changed after positioning the surgical sleeve.
  • Action
    Straumann notified accounts of this correction by letter dated September 30, 2010 and delivered via Federal Express Delivery Service. The upgrade is available on-line by logging into the coDiagnostiX system and enabling the automatic upgrade to occur.

Device

Straumann coDiagnostiX
  • Model / Serial
    Article Number Description Version 019.0333 Offline Upgrade CDX Station 7 EN (6+) 7.0.2.10 019.0334 Offline Upgrade CDX PPP 7 EN 7.0.2.10 019.0343 coDiagnostiX Station V 7.0 EN 7.0.2.10 019.0344 coDiagnostiX PPP V 7.0 EN 7.0.2.10 019.0345 coDiagnostiX coDoctor V 7.0 EN 7.0.2.10
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Straumann coDiagnostiX, dental implant planning system. || Software Version 7.0 including updates 7.0.2 and 7.0.2.10
  • 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