Globus Medical Cranial Drill recalled for potential sterility compromise
Globus Medical is recalling Cranial Drills due to potential sterility loss from packaging breaches and discoloration at the drill tip. The drills are used in cranial surgery with the ExcelsiusGPS system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device where sterility compromise in surgical instruments poses a risk of infection. No illnesses or injuries have been reported. This meets the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Globus Medical, Inc. is recalling Cranial Drills with Stop, 3.20mm, which are used for cranial device access, preparation, and placement with the ExcelsiusGPS system.
Sterile-packed drills in this recall may not be sterile due to breaches in packaging and/or may have discoloration near the drill tip. These defects could impact instrument integrity during surgical use.
The recall affects devices distributed worldwide, including the United States, Czech Republic, and Poland. Affected devices can be identified by their UDI codes listed in the FDA recall notice.
The recalled product
- Product
- Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S
- Manufacturer
- Globus Medical, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot: UDI: GBY097VA (01)00193982302269(17)280313(10)GBY097VA
- GBY097RA (01)00193982302269(17)280313(10)GBY097RA
- GBY097JA (01)00193982302269(17)280313(10)GBY097JA
- GBY097HA (01)00193982302269(17)280313(10)GBY097HA
- GBY097GA (01)00193982302269(17)280313(10)GBY097GA
- GBY097VA-RB (01)00193982302269(17)280313(10)GBY097VA-RB
- GBY097RA-RB (01)00193982302269(17)280313(10)GBY097RA-RB
- GBY097JA-RB (01)00193982302269(17)280313(10)GBY097JA-RB
- GBY097HA-RB (01)00193982302269(17)280313(10)GBY097HA-RB
- GBY097GA-RB (01)00193982302269(17)280313(10)GBY097GA-RB
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Globus Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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