FDA-Device2017-05-24Class II

Navitrack System - OS Knee Universal, Stereotaxic instrument

Orthosoft, Inc. dba Zimmer CAS
Hazard

Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .

Sold states
Domestic: CA, FL, GA, IL, IN, KS, NC, NY, OH, OR, PA, RI, TN, TX, VA, WA Foreign: Canada, Australia Austria Brazil China Czech Republic France Germany Israel Italy Lebanon Luxembourg Netherlands New Zealand Spain Sweden Switzerland United Kingdom
Affected count
153
Manufactured in
75 Queen St #3300, Montreal, Canada
Products
Navitrack System - OS Knee Universal, Stereotaxic instrument

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2076-2017

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