# FDA recall Z-2330-2020

> **Medtronic Navigation, Inc.** · Class II · device recall initiated 2019-12-05.

## Product

Mazor X Surgical System Positioner Type II, REF: ASM0214-02

## Reason for recall

There is a potential for the surgical system to detach from the operational room table unexpectedly.  This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)]

## Distribution

US: ALAR,AZ,CA,CO,CT,FL,GA,IA,ID,IL,IN,KY,MA,MI,MN,MO,NC,ND,NL,NY,OH,PA,SC,TN,TX,UT,VA,WA,WI,WV,  OUS: Australia, China, India, Israel, Romania, Singapore, Thailand, United Kingdom, Switzerland, Spain, Germany, Belgium,

## Key facts

- **Recall number:** Z-2330-2020
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-12-05
- **Report date:** 2020-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2330-2020

## Citation

> AI Analytics. FDA recall Z-2330-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2330-2020. Source: US FDA. Licensed CC0.

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