RecallRadar

FDA Device recall Z-2924-2018

Stryker Mako Vizadisc Knee Procedure Tracking Kit

On 2018-09-05 the FDA classified a Class II recall of Stryker Mako Vizadisc Knee Procedure Tracking Kit by Mako Surgical, citing 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 i….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2924-2018
ClassificationClass II
Statusterminated
Initiated2018-07-24
Published2018-09-05
Last updated2026-09-13 11:54 UTC
CompanyMako Surgical
DistributionAK, AL, AR, AZ, CA, CO, CT, FL, IA, ID, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI

Product

Stryker Mako Vizadisc Knee Procedure Tracking Kit

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.

Identifiers

code_infoCatalog Number 107120. Lot Numbers 17097K, 17124K, 17129K, 17136K, 17143K, 17103H. **EXPANSION** Lot Numbers 17007K, 17013K, 17024K, 17035K, 17054K, 16354H.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2924-2018%22

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