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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 September 13, 2011
Recall Status1 Terminated on May 23, 2012
Recall Number Z-3184-2011
Recall Event ID 59797
Premarket Notification
510(K) Number
K071636 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the proper selection of an oral drill. Imaging processing System
Code Information Software version 8.0 as listed below: listed are the affected articles. Internet Upgrade: 019,0385 @ Upgrade cDX 8 PPP (7+) 019,0386 @ Upgrade cDX 8 Station (7+) 019.0387 @ Upgrade cDx 8 coDoctor (7+) 019.0388 @ Upgrade cDX coDoctor (7+) > PPP 8 0'19.0389 @ Upgrade cDX codoctor (7+) > PPG 8 019.0390 @ Upgrade cDX coDoctor (7+) >Station 8 019.0391 @ Upgrade cDX PPP (7 +):> PPG 8 019.0392 @ Upgrade cDX PPP (7+):> Station 8 019.0393 @ Upgrade coDX PPP > Station 8 Offline Upgrades: 019.0378 Upgrade coDiagnostix 8 PPP (7-) 0'19.0379 Upgrade coDiagnostiX 8 Station (7-) 019.0380 Upgrade coDiagnostiX 8 coDoctor (7-) 019.0381 Upgrade coDoctor (7-) -> PPP 8 019.0382 Upgrade coDoctor (7-) -> PPG8 019.0383 Upgrade PPP (7-) -> PPG 8 019.0384 coDiagnostiX CD coDlagnostiX licenses: 019.0370 coDiagnostiX 8 PPP 019.0371 coDiagnostiX 8 PPG 0'19.0372 coDiagnostiX 8 Station, and 019.0373 coDiagnositX 8 coDoctor.
Recalling Firm/
Manufacturer
Straumann Manufacturing Inc.
60 Minuteman Rd
Andover, Massachusetts 01810-1008
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact SAME
800-448-8168
Manufacturer Reason
for Recall
Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed.
FDA Determined
Cause 2
DESIGN: Software Design
Action Staumann USA notified accounts by an Urgent Field Safety Notice letter dated August 4, 2011 and delivered via Federal Express Delivery Service. The letter identified the affected product and explained the reason for the recall. Customers were asked to review the letter, take appropriate actions, including completing and faxing the enclosed. Customer Confirmation Form. Straumann released a corrected software upgrade (coDiagnostiX 8.0.2.3672), which is available for download when users go online and activate current software. If the user does not have internet access a replacement CD can be ordered from Technical Support at 866 - 531 -7365. Questions should be directed to Technical Support Monday through Friday from 8:00 am to 8:00 pm Eastern Time.
Quantity in Commerce 272
Distribution Nationwide Distribution
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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