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Orthosoft, Inc. dba Zimmer CAS recalls Navitrack System - OS Knee Universal, Stereotaxic instrument
Recalled May 24, 2017 · FDA recall Z-2076-2017 · Orthosoft, Inc.
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 . · FDA Class II
Units
153
Sold at
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
Description
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 .
Product
Navitrack System - OS Knee Universal, Stereotaxic instrument
Manufacturer(s)
Orthosoft, Inc. dba Zimmer CAS
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →