Company:Straumann Manufacturing Inc
Date of Enforcement Report 11/16/11
Class ll:
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. Recall # Z-3184-2011
REASON
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.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Straumann Manufacturing Inc., Andover, MA, by letter dated August 4, 2011.
Manufacturer: Institut Straumann AG, Basel, Switzerland. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
272 units
DISTRIBUTION
Nationwide