Device product

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

Z-0995-2024

December 11, 2023

Class II

Product summary

Firm: Globus Medical, Inc.
Event: Event 93742
Status: Ongoing
Classification: Class II
Quantity: Unavailable
Official record key: device-enforcement:Z-0995-2024

Official wording

Reason: Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.

Code information: 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

Distribution pattern: Worldwide - US Nationwide and the countries of Czech Republic, Poland.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.