Mar

2009

OS Unicondylar Knee 1, Cl ll Orthosoft Navitrack

Company: Zimmer, Inc
Date of Enforcement Report 3/11/2009
Class:ll

PRODUCT
Orthosoft Navitrack, OS Unicondylar Knee 1.0 – Universal; software application for orthopedic surgical stereotaxic instrument. Recall # Z-0985-2009

REASON
Incorrect parameters: If the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks, the application will continue to use the initial surgeon profile parameter values in the calculation of the predicted hip-knee-ankle alignment estimates, which may have different resection or component thickness parameters than are appropriate for the specific patient involved.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated August 19, 2008.
Manufacturer: Zimmer CAS, Montreal, Quebec Canada. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
76 total (34 U.S. and 41 international)

DISTRIBUTION
Nationwide and Internationallyp>

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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OS Unicondylar Knee 1, Cl ll Orthosoft Navitrack

Amy Sellers

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