Recall Z-0995-2024 ยท HAW Neurological Stereotaxic Instrument
Globus Medical, Inc.
Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
| Date | Feb 6, 2024 (initiated Dec 11, 2023) |
| Status | Open, Classified |
| Reason | 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 | 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: recall@globusmedica |
| Distribution | Worldwide - US Nationwide and the countries of Czech Republic, Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200047 | ExcelsiusGPS Cranial 1.0 Module Globus Medical, Inc., Jul 10, 2020 |