Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S
FDA Recall Z-0996-2024 · Posted 2024-02-06
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Recalling FirmGlobus Medical, Inc.
Recall StatusOpen, Classified
Product CodeHAW
Date Initiated2023-12-11
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.
Firm 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
Root Cause
Package design/selection
Distribution Pattern
Worldwide - US Nationwide and the countries of Czech Republic, Poland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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