FDA recall Z-0997-2024

Globus Medical, Inc. · Class II · device

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

Status
Ongoing
Initiation date
2023-12-11
Report date
2024-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Audubon, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0997-2024