# FDA recall Z-3182-2018

> **Mako Surgical Corporation** · Class II · device recall initiated 2017-12-27.

## Product

Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933    Product Usage:  The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.

## Reason for recall

Communication-connection error.

## Distribution

Worldwide Distribution - US Nationwide and the countries of   Australia, New Zealand, Taiwan, China, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Germany, Ireland, Switzerland, Italy, India, Japan, South Korea, Vietnam, South Africa, and Turkey,

## Key facts

- **Recall number:** Z-3182-2018
- **Recalling firm:** Mako Surgical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-27
- **Report date:** 2018-09-26
- **Termination date:** 2020-12-14

- **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-3182-2018

## Citation

> AI Analytics. FDA recall Z-3182-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-3182-2018. Source: US FDA. Licensed CC0.

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