Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
Recall
- Recall Number
- Z-0997-2024
- Event Number
- 93742
- Firm
- Globus Medical, Inc.
- FEI Number
- 3004142400
- Product Code
- HAW
- Status
- Open, Classified
- Root Cause
- Package design/selection
- Initiated
- December 11, 2023
- Posted
- February 6, 2024
- Address
- 2560 General Armistead Ave, Audubon, PA, 19403-5214
Description
Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
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
Worldwide - US Nationwide and the countries of Czech Republic, Poland.