• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Straumann coDiagnostiX

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
 Class 2 Recall
Straumann coDiagnostiX
see related information
Date Posted March 07, 2011
Recall Status1 Terminated on September 19, 2011
Recall Number Z-1592-2011
Recall Event ID 56994
Premarket Notification
510(K) Number
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and
Code Information Article Number Description Version 019.0333 Offline Upgrade CDX Station 7 EN (6+) 019.0334 Offline Upgrade CDX PPP 7 EN 019.0343 coDiagnostiX Station V 7.0 EN 019.0344 coDiagnostiX PPP V 7.0 EN 019.0345 coDiagnostiX coDoctor V 7.0 EN
Recalling Firm/
Straumann Manufacturing Inc.
60 Minuteman Rd
Andover, Massachusetts 01810
For Additional Information Contact Bernard M. McDonald
Manufacturer Reason
for Recall
Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 20 systems
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = IVS SOLUTIONS AG