FDAFDA · Food and drugs·Recall number Z-0995-2024
Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
Published February 14, 2024 · Recall initiated: December 11, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Globus Medical, Inc.
- Distributor
- Worldwide - US Nationwide and the countries of Czech Republic, Poland.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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