# FDA recall Z-2135-2024

> **Blue Belt Technologies, Inc** · Class II · device recall initiated 2024-05-07.

## Product

CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures  Product Numbers:   (1) ROB10000	CORI Starter Kit	  (2) ROB10024	Real Intelligence CORI	  (3) ROB10197	CORI STARTER KIT - UNIVERSAL	  Note: the three product numbers cover the three different configurations in which the CORI Console is sold

## Reason for recall

CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay

## Distribution

Nationwide Foreign: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, UK

## Key facts

- **Recall number:** Z-2135-2024
- **Recalling firm:** Blue Belt Technologies, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-07
- **Report date:** 2024-06-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pittsburgh, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2135-2024

## Citation

> AI Analytics. FDA recall Z-2135-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2135-2024. Source: US FDA. Licensed CC0.

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