medical Class II Updated 2018-09-05

Mako Surgical Corporation recalls Stryker Mako Vizadisc Hip Procedure Tracking Kit

Recalled Product

Stryker Mako Vizadisc Hip Procedure Tracking Kit


Hazard / Issue

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.

Issued by

FDA

Affected 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
Lot/Code Info: Catalog Number 107130. Lot Numbers 17097K, 17124K, 17129K, 17136K, 17143K, 17103H. **EXPANSION** Lot Numbers 17007K, 17013K, 17024K, 17035K, 17054K, 16354H.
View official government recall

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