# FDA recall Z-1644-2018

> **Mako Surgical Corporation** · Class II · device recall initiated 2017-12-01.

## Product

RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

## Reason for recall

Incorrect product and/or label. Sizing is labeled incorrectly.

## Distribution

AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY,  and Hawaii  Australia, Italy, Netherlands, Singapore, South Korea, United Kingdom, and   Vietnam

## Key facts

- **Recall number:** Z-1644-2018
- **Recalling firm:** Mako Surgical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-01
- **Report date:** 2018-05-16
- **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-1644-2018

## Citation

> AI Analytics. FDA recall Z-1644-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1644-2018. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*