Globus Medical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0996-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: December 11, 2023
Date Posted: February 14, 2024
Recall Number: Z-0996-2024
Event ID: 93742
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.

Status: Ongoing
Product Quantity:
Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated