Globus Medical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0997-2024)

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

Product Classification:

Class II

Date Initiated: December 11, 2023

Date Posted: February 14, 2024

Recall Number: Z-0997-2024

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 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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated