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Recall Observatory FDA recall evidence

Device product

Stryker Mako Vizadisc Hip Procedure Tracking Kit

Z-2925-2018

July 24, 2018

Class II

Product summary

Firm
Mako Surgical Corporation
Event
Event 80621
Status
Terminated
Classification
Class II
Quantity
19,906 total devices
Official record key
device-enforcement:Z-2925-2018

Official wording

Reason: 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.

Code information: Catalog Number 107130. Lot Numbers 17097K, 17124K, 17129K, 17136K, 17143K, 17103H. **EXPANSION** Lot Numbers 17007K, 17013K, 17024K, 17035K, 17054K, 16354H.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.