# FDA recall Z-2925-2018

> **Mako Surgical Corporation** · Class II · device recall initiated 2018-07-24.

## Product

Stryker Mako Vizadisc Hip Procedure Tracking Kit

## Reason for 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.

## 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.

## Key facts

- **Recall number:** Z-2925-2018
- **Recalling firm:** Mako Surgical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-24
- **Report date:** 2018-09-05
- **Termination date:** 2022-10-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Davie, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2925-2018

## Citation

> AI Analytics. FDA recall Z-2925-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2925-2018. Source: US FDA. Licensed CC0.

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