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U.S. Department of Health and Human Services

Class 2 Device Recall Straumann coDiagnostiX

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 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
K071636 
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 7.0.2.10
Code Information 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
Recalling Firm/
Manufacturer
Straumann Manufacturing Inc.
60 Minuteman Rd
Andover, Massachusetts 01810
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Bernard M. McDonald
978-747-2514
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
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