# FDA recall Z-0997-2024

> **Globus Medical, Inc.** · Class II · device recall initiated 2023-12-11.

## Product

Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS.    	  Ref: 6143.1870S

## Reason for recall

Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.

## Distribution

Worldwide - US Nationwide and the countries of Czech Republic, Poland.

## Key facts

- **Recall number:** Z-0997-2024
- **Recalling firm:** Globus Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-11
- **Report date:** 2024-02-14

- **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-0997-2024

## Citation

> AI Analytics. FDA recall Z-0997-2024. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-0997-2024. Source: US FDA. Licensed CC0.

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