# FDA recall Z-2100-2018

> **VGI Medical, LLC** · Class II · device recall initiated 2018-04-09.

## Product

VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

## Reason for recall

IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated

## Distribution

Distributed to MI, FL, and NY.

## Key facts

- **Recall number:** Z-2100-2018
- **Recalling firm:** VGI Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-09
- **Report date:** 2018-06-13
- **Termination date:** 2020-08-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Seminole, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2100-2018

## Citation

> AI Analytics. FDA recall Z-2100-2018. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-2100-2018. Source: US FDA. Licensed CC0.

---

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