Globus Medical Cranial Drill — Class II medical device recall Z-0997-2024
Ongoing recall by Globus Medical, Inc., reported 2024-02-14, distributed nationwide. Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloratio
| Recall number | Z-0997-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Globus Medical, Inc., Audubon, PA, United States |
| Recall initiated | 2023-12-11 |
| Classified | 2024-02-06 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CZ, PL |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00193982302320 |
| Lot numbers | GBY093VA, GBY093VA-RB, GBY093XA, GBY093XA-RB, GBY094HA, GBY094HA-RB, GBY094JA, GBY094JA-RB, GBY094MA, GBY094MA-RB, GBY094NA, GBY094NA-RB |
| Model numbers | 6143.1870S |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0997-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.