dental implant plan, Cl ll Straumann coDiagnostiX

Company: Straumann Manufacturing Inc
Date of Enforcement Report 3/16/2011
Class ll:

PRODUCT
Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10. Recall # Z-1592-2011

REASON
Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Straumann Manufacturing Inc., Andover, MA, by letter dated September 30, 2010.
Manufacturer: Instituit Strauman, Basel, Switzerland. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
70 units

DISTRIBUTION
Nationwide

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.