# FDA recall Z-2051-2018

> **Mako Surgical Corporation** · Class II · device recall initiated 2018-01-19.

## Product

Restoris MCK Onlay Insert Extractor.

## Reason for recall

Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

## Distribution

Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI.      Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.

## Key facts

- **Recall number:** Z-2051-2018
- **Recalling firm:** Mako Surgical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-19
- **Report date:** 2018-06-13
- **Termination date:** 2020-09-16

- **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-2051-2018

## Citation

> AI Analytics. FDA recall Z-2051-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2051-2018. Source: US FDA. Licensed CC0.

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