Mako Surgical Corporation recalls Stryker Mako Vizadisc Knee Procedure Tracking Kit

Recall date

July 24, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2924-2018

FDA classification

Class II

Brand / firm

Mako Surgical Corporation

Sold / distributed

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.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stryker Mako Vizadisc Knee Procedure Tracking Kit