Globus Medical Cranial Drills recalled for sterility loss and discoloration
Globus Medical is recalling Cranial Drills (2.40mm) due to packaging breaches that may compromise sterility and discoloration near the drill tip. Distributed worldwide.
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: This is an FDA Class II recall of sterile surgical instruments with packaging breaches that may compromise sterility. While no illnesses or injuries have been reported, non-sterile instruments used in cranial procedures present a significant risk of surgical site infection, meeting the criterion for high-risk products where harm has not yet been reported.
Plain-English summary
Globus Medical is recalling its Cranial Drill with Stop (2.40mm), a surgical instrument used in cranial device placement with the ExcelsiusGPS system. The sterile-packed drills may not be sterile due to packaging breaches and may show discoloration near the drill tip.
Healthcare facilities that received affected units should cease use immediately and contact Globus Medical for replacement or return instructions. The affected drills were distributed worldwide, including to healthcare providers in the US, Czech Republic, and Poland. The FDA has assigned recall number Z-0995-2024 to this Class II recall.
The recalled product
- Product
- Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
- 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 (7)
- Lot: UDI: GBB156EB (01)00193982302238(17)300425(10)GBB156EB
- GBY098JA (01)00193982302238(17)280315(10)GBY098JA
- GBY098HA (01)00193982302238(17)280315(10)GBY098HA
- GBY097FA (01)00193982302238(17)280312(10)GBY097FA
- GBY098JA-RB (01)00193982302238(17)280315(10)GBY098JA-RB
- GBY098HA-RB (01)00193982302238(17)280315(10)GBY098HA-RB
- GBY097FA-RB (01)00193982302238(17)280312(10)GBY097FA-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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