Home / Recalls / Globus Medical, Inc. / Z-0997-2024

Z-0997-2024 Class II Ongoing

Recalled by Globus Medical, Inc. — Audubon, PA

Recall Details

Product Type
Devices
Report Date
February 14, 2024
Initiation Date
December 11, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

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

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 Pattern

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

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

Other recalls by Globus Medical, Inc.

  • Z-1657-2025 Class II — MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; (April 3, 2025)
  • Z-1007-2024 Class II — ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No (December 15, 2023)
  • Z-0996-2024 Class II — Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, prepar (December 11, 2023)
  • Z-0995-2024 Class II — Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, prepara (December 11, 2023)
  • Z-0642-2024 Class I — ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 (December 7, 2023)
  • Z-2863-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿ (July 22, 2020)
  • Z-2854-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿ (July 22, 2020)
  • Z-2851-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿ (July 22, 2020)
  • Z-2862-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿ (July 22, 2020)
  • Z-2855-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿ (July 22, 2020)