FDA-Device2018-09-05Class II
Stryker Mako Vizadisc Knee Procedure Tracking Kit
Mako Surgical Corporation
Hazard
Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
Sold states
All devices were distributed in the US in the following states: AK, AL, AR, AZ, CA, CO, CT, FL, IA, ID, KS, KY, LA, MA, MD, MI, MN, MO, NE, NC, NH, NJ, NY, NV, OH, PA, RI, SC, SD, TN. TX, UT, VA, WA, WI.
Affected count
19,906 total devices
Manufactured in
2555 Davie Rd Ste 110, N/A, Davie, FL, United States
Products
Stryker Mako Vizadisc Knee Procedure Tracking Kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2924-2018Don't want to check this manually?
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