Globus Medical, Inc.: Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S

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.

Details from the source

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. Distribution: Worldwide - US Nationwide and the countries of Czech Republic, Poland. Lot/code info: 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

UPC codes

00193982302238

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.