# FDA recall Z-0642-2024

> **Globus Medical, Inc.** · Class I · device recall initiated 2023-12-07.

## Product

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

## Reason for recall

A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.

## Distribution

Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.

## Key facts

- **Recall number:** Z-0642-2024
- **Recalling firm:** Globus Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-07
- **Report date:** 2024-01-24

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0642-2024

## Citation

> AI Analytics. FDA recall Z-0642-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0642-2024. Source: US FDA. Licensed CC0.

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