FDA-Device2017-05-03Class II
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Orthosoft, Inc. dba Zimmer CAS
Hazard
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.
Sold states
Worldwide Distribution - US including AZ CA CO FL GA IL IN KS MD MI MN MS OH OR PA SC SD TX VA WA and WI Internationally to Canada, Australia Austria Colombia Denmark France Germany Korea New Zealand Russia South Africa and Thailand
Affected count
105
Manufactured in
75 Queen St #3300, N/A, Montreal, N/A, Canada
Products
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1881-2017Don't want to check this manually?
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