Globus Medical Cranial Drill recalled for sterility breach risk
Globus Medical is recalling Cranial Drill 6.00mm units due to potential packaging breaches that may render the sterile product non-sterile, and discoloration near the drill tip.
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 recall of a surgical instrument with potential sterility breach, which is a significant risk-of-harm for patients undergoing cranial procedures. No illnesses or injuries are reported in the source text, keeping the score at High rather than Severe.
Plain-English summary
Globus Medical, Inc. is recalling the Cranial Drill, 6.00mm (Reference 6143.1870S), used for cranial access, preparation, and placement of cranial devices with the ExcelsiusGPS system.
The recalled drills may not be sterile due to breaches in packaging. Additionally, some units may have discoloration near the drill tip. These issues affect multiple lot numbers distributed worldwide, including the US, Czech Republic, and Poland.
Healthcare facilities and surgical teams using this instrument should verify lot numbers against the recall notice and discontinue use of affected units immediately. Any patient who may have been exposed to a potentially non-sterile instrument should be assessed by their medical team.
The recalled product
- Product
- Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
- 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 (12)
- Lot Number UDI: GBY094NA (01)00193982302320(17)280311(10)GBY094NA
- GBY094MA (01)00193982302320(17)280311(10)GBY094MA
- GBY094JA (01)00193982302320(17)280311(10)GBY094JA
- GBY094HA (01)00193982302320(17)280311(10)GBY094HA
- GBY093XA (01)00193982302320(17)280311(10)GBY093XA
- GBY093VA (01)00193982302320(17)280311(10)GBY093VA
- GBY094NA-RB (01)00193982302320(17)280311(10)GBY094NA-RB
- GBY094MA-RB (01)00193982302320(17)280311(10)GBY094MA-RB
- GBY094JA-RB (01)00193982302320(17)280311(10)GBY094JA-RB
- GBY094HA-RB (01)00193982302320(17)280311(10)GBY094HA-RB
- GBY093XA-RB (01)00193982302320(17)280311(10)GBY093XA-RB
- GBY093VA-RB (01)00193982302320(17)280311(10)GBY093VA-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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