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Orthosoft, Inc. dba Zimmer CAS recalls Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in
Recalled May 3, 2017 · FDA recall Z-1881-2017 · Orthosoft, Inc.
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. · FDA Class II
Units
105
Sold at
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
Description
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.
Product
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Manufacturer(s)
Orthosoft, Inc. dba Zimmer CAS
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →