Globus Medical, Inc.: Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S

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: 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

UPC codes

00193982302269

Source

Official record: FDA (Device enforcement) ↗

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