Date Initiated by Firm |
September 30, 2010 |
Date Posted |
March 07, 2011 |
Recall Status1 |
Terminated 3 on September 19, 2011 |
Recall Number |
Z-1592-2011 |
Recall Event ID |
56994 |
510(K)Number |
K071636
|
Product Classification |
dental implant planning system - 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 MA 01810
|
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 |
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = IVS SOLUTIONS AG
|