Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the Ex
FDA device recall Z-0997-2024 · posted 2024-02-06 · Open, Classified
Recall details
- Recalling firm
- Globus Medical, Inc.
- 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.
- Action taken
- 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@globusmedical.com Recall Related Questions
- Root cause
- Package design/selection
- Status
- Open, Classified
- Product code
- HAW
- Distribution
- Worldwide - US Nationwide and the countries of Czech Republic, Poland.
- Date initiated
- 2023-12-11
- Date posted
- 2024-02-06
- Location
- Audubon, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ExcelsiusGPS Cranial 1.0 Module (K200047) | Globus Medical, Inc. | 2020-07-10 |