Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placeme...
FDA Recall #Z-0995-2024 — Class II — December 11, 2023
Product Description
Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
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.
Recalling Firm
Globus Medical, Inc. — Audubon, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
Worldwide - US Nationwide and the countries of Czech Republic, Poland.
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated