Globus Medical, Inc.: Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S

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 Number UDI: GBY094NA (01)00193982302320(17)280311(10)GBY094NA; GBY094MA (01)00193982302320(17)280311(10)GBY094MA; GBY094JA (01)00193982302320(17)280311(10)GBY094JA; GBY094HA (01)00193982302320(17)280311(10)GBY094HA; GBY093XA (01)00193982302320(17)280311(10)GBY093XA; GBY093VA (01)00193982302320(17)280311(10)GBY093VA; GBY094NA-RB (01)00193982302320(17)280311(10)GBY094NA-RB; GBY094MA-RB (01)00193982302320(17)280311(10)GBY094MA-RB; GBY094JA-RB (01)00193982302320(17)280311(10)GBY094JA-RB; GBY094HA-RB (01)00193982302320(17)280311(10)GBY094HA-RB; GBY093XA-RB (01)00193982302320(17)280311(10)GBY093XA-RB; GBY093VA-RB (01)00193982302320(17)280311(10)GBY093VA-RB

UPC codes

00193982302320

Source

Official record: FDA (Device enforcement) ↗

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