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Open, Classified

Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S

FDA Recall Z-0995-2024 · Posted 2024-02-06

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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