Company: Straumann Manufacturing Inc
Date of Enforcement Report 3/16/2011
Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 188.8.131.52. Recall # Z-1592-2011
Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.
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