# FDA recall Z-3131-2017

> **Mako Surgical Corporation** · Class II · device recall initiated 2017-08-07.

## Product

Total Hip Application (THA)     Product Usage:  The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

## Reason for recall

Software discrepancy of not showing all the EE constants, when the screen is filled.

## Distribution

Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY  and the countries of   Australia, Taiwan, China, Taiwan, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Ireland, Italy, Germany, India, Japan, Korea, Singapore, Thailand, Vietnam, South Africa, and Turkey

## Key facts

- **Recall number:** Z-3131-2017
- **Recalling firm:** Mako Surgical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-07
- **Report date:** 2017-09-20
- **Termination date:** 2019-08-06

- **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-3131-2017

## Citation

> AI Analytics. FDA recall Z-3131-2017. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-3131-2017. Source: US FDA. Licensed CC0.

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