Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stryker Mako Vizadisc Knee Procedure Tracking Kit Recalled by Mako Surgical Corporation Due to Specific lots of the Vizadisc Knee Procedure Tracking...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mako Surgical Corporation directly.
Affected Products
Stryker Mako Vizadisc Knee Procedure Tracking Kit
Quantity: 19,906 total devices
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 35 states: AL, AK, AZ, AR, CA, CO, CT, FL, ID, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NY, NC, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI
About Mako Surgical Corporation
Mako Surgical Corporation has 27 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report