Reported Feb 14, 2024 · Ongoing
Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices…
Globus Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Globus Medical, Inc. · 2560 General Armistead Ave · Audubon, PA · 19403-5214
Is this the product you have?
- Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS
- Ref6143.1834S
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 00193982302238Lot: UDI: GBB156EB (01)00193982302238(17)300425(10)GBB156EB 2 00193982302238GBY098JA (01)00193982302238(17)280315(10)GBY098JA 3 00193982302238GBY098HA (01)00193982302238(17)280315(10)GBY098HA 4 00193982302238GBY097FA (01)00193982302238(17)280312(10)GBY097FA 5 00193982302238GBY098JA-RB (01)00193982302238(17)280315(10)GBY098JA-RB 6 00193982302238GBY098HA-RB (01)00193982302238(17)280315(10)GBY098HA-RB 7 00193982302238GBY097FA-RB (01)00193982302238(17)280312(10)GBY097FA-RB
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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