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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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