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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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