PlainRecalls
FDA Devices Moderate Class II Ongoing

Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S

Reported: February 14, 2024 Initiated: December 11, 2023 #Z-0996-2024

Product Description

Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S

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.

Details

Recalling Firm
Globus Medical, Inc.
Distribution
Worldwide - US Nationwide and the countries of Czech Republic, Poland.
Location
Audubon, PA

Frequently Asked Questions

What product was recalled?
Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S. Recalled by Globus Medical, Inc..
Why was this product recalled?
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-0996-2024.