CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
Cranial Drill with Stop - instruments for access recalled
Globus Medical is recalling Cranial Drill with Stop - instruments for access, preparation, and placement of cranial, distributed nationwide in the US. The recall was initiated on 11 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0996-2024
- FDA event ID
- 93742
- Recalling firm
- Globus Medical, Audubon, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Dec 2023
- FDA classified
- 6 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 11 Dec 2023 | Recall initiated by company | |
| 6 Feb 2024 | Classified by FDA | +57 days |
| 14 Feb 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S
Where it was distributed
Worldwide - US Nationwide and the countries of Czech Republic, Poland.
Questions about this recall
Why was it 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 lots are affected?
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
Where was it sold?
Worldwide - US Nationwide and the countries of Czech Republic, Poland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93742This product is part of a recall event; the main page for the event is Cranial Drill - instruments for access, preparation recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cranial Drill - instruments for access, preparation recalled | Globus Medical | Sterility | Nationwide | |
| CLASS II | Cranial Drill with Stop - Instruments for access recalled | Globus Medical | Sterility | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | Cranial Drill with Stop - Instruments for access recalled | Globus Medical | Sterility | Nationwide |
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