Lower risk Medical device recall · FDA · Published July 24, 2018

Stryker Mako Vizadisc Knee Tracking Kit Recall: Reflective Material May Not Detect

Stryker Mako recalls specific lots of Vizadisc Knee Procedure Tracking Kit due to reflective material damage causing camera detection issues. Affected units include catalog numbers 107120 with listed lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2924-2018Medical device Stryker Mako ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmMako Surgical Corporation2555 Davie Rd Ste 110 · Davie, FL 33317-7424

✎ GovInfoNow plain-language explainer

Stryker Mako is recalling specific lots of the Vizadisc Knee Procedure Tracking Kit because the reflective material may become damaged, preventing camera detection. This could lead to tracking issues during surgical procedures. The recall affects only specific lot numbers and catalog numbers. Read more at govinfonow.com/recall/70303-stryker-mako-vizadisc-knee-tracking-kit-recall-reflective-material-may.

Source Summary by GovInfoNow · govinfonow.com/recall/70303-stryker-mako-vizadisc-knee-tracking-kit-recall-reflective-material-may · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2924-2018

Cite this page

“Stryker Mako Vizadisc Knee Tracking Kit Recall: Reflective Material May Not Detect.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70303-stryker-mako-vizadisc-knee-tracking-kit-recall-reflective-material-may. Based on FDA recall #Z-2924-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2924-2018%22&limit=1).

The FDA announced on July 24, 2018, that Mako Surgical Corporation voluntarily recalled Stryker Mako Vizadisc Knee Procedure Tracking Kits due to potential damage to reflective material. The hazard prevents detection by the camera during procedures. This Class II recall affected 19,906 devices distributed across the United States.

How to tell if you have it

Brand: Stryker Mako
Product: Vizadisc Knee Procedure Tracking Kit
Catalog Number: 107120
Lot Numbers: 17097K, 17124K, 17129K, 17136K, 17143K, 17103H, 17007K, 17013K, 17024K, 17035K, 17054K, 16354H

The hazard

Specific lots of the Vizadisc Knee Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material. This damage causes an inability to be detected by the camera.

Context

GovInfoNow's records show Mako Surgical Corporation has 10 other recalls on record since June 7, 2017. Other recent recalls of similar products include Stryker BARD Dynamic Tip Steerable Recall (April 23, 2026) and Kico Knee Innovation Arvis Hip & Knee 2.0 Instrument Set Recall (April 23, 2026).

How to tell if you have this one

Check the catalog number (107120) and lot numbers listed: 17007K, 17013K, 17024K, 17035K, 17054K, 16354H, 17097K, 17124K, 17129K, 17136K, 17143K, 17103H.

Brand
Stryker Mako
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
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.

Recall number	Product, codes & lots
Z-2924-2018	Stryker Mako Vizadisc Knee Procedure Tracking Kit; Catalog Number 107120. Lot Numbers 17097K, 17124K, 17129K, 17136K, 17143K, 17103H. EXPANSION Lot Numbers 17007K, 17013K, 17024K, 17035K, 17054K, 16354H.
Z-2925-2018	Stryker Mako Vizadisc Hip Procedure Tracking Kit; Catalog Number 107130. Lot Numbers 17097K, 17124K, 17129K, 17136K, 17143K, 17103H. EXPANSION Lot Numbers 17007K, 17013K, 17024K, 17035K, 17054K, 16354H.

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the catalog number (107120) and lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in 35 states.

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Idaho, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 4.2 years after the firm started it.

Jul 24, 2018Firm started the recall
Aug 24, 2018FDA classified it Class II
Sep 5, 2018Published in FDA’s Enforcement Report
Oct 11, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to do anything if I have the kit?

The recall does not require immediate action; check the lot numbers to see if your kit is affected.

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Link to this recall

<a href="https://govinfonow.com/recall/70303-stryker-mako-vizadisc-knee-tracking-kit-recall-reflective-material-may">Stryker Mako Vizadisc Knee Tracking Kit Recall: Reflective Material May Not Detect (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2924-2018 (July 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2924-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.