Z-0997-2024Class II

Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices...

Name: Z-0997-2024 Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices...
Creator: Globus Medical, Inc.
Published: 2023-12-11
License: https://open.fda.gov/license/

Globus Medical, Inc. / initiated 2023-12-11 / Open, Classified / root cause: packaging

FDA source

Globus Medical, Inc. began a recall of Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S on 2023-12-11. FDA classified it as Class II and gives the reason as "Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0997-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-11
Posted: 2024-02-06
Recalling firm: Globus Medical, Inc.
Product: Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Globus Medical issued Urgent Medical Device Recall Notification letter on 12/11/23. Letter states reason for recall, health risk and action to take: Customers are instructed to immediately return all affected sterile-packed Cranial Drills to Globus Medical and complete the attached Response Card. Report any adverse events believed to be associated with the affected sterile-packed Cranial Drills to Globus Medical immediately. For Questions and Support: Globus Medical Contact Contact Information Areas of Support Globus Medical Complaint Handling Unit Fax: 610-300-1342 Email: [email protected] Recall Related Questions
Distribution: Worldwide - US Nationwide and the countries of Czech Republic, Poland.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0997-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0995-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-06
Z-0996-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-06
Z-0997-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-06

Product code HAW

K200047Class IIExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc. / cleared 2020-07-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)