May

2017

Orthosoft Navitrack System Cl II

Company: Orthosoft, Inc. dba Zimmer CAS.
Date of Enforcement Report 5/3/2017
Class lI:

PRODUCT

Navitrack System – OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Recall Number Z-1881-2017

REASON
Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System – OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.

RECALLING FIRM/MANUFACTURER
Orthosoft, Inc. dba Zimmer CAS, Montreal Canada on 10/6/2011. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
105

DISTRIBUTION
Nationwide and Internationally.

___________________________________

About the author

Amy Sellers

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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Orthosoft Navitrack System Cl II

Amy Sellers

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