EXCELSIUS GPS recallZ-0996-2024 · Globus Medical, Inc. · initiated Dec 11, 2023

Why it was recalled

Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.

FDA root cause category: Package design/selection

What the company is doing

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

Recall details

Recall number

Z-0996-2024

Status

Open, Classified

Initiated by the company

Dec 11, 2023

Posted by the FDA

Feb 6, 2024

Recalling firm

Globus Medical, Inc.

Product code

HAW

FDA submissions

K200047

Distribution

Worldwide - US Nationwide and the countries of Czech Republic, Poland.

Product description

Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• EXCELSIUS GPS 6143.1842S

  Globus Medical, Inc. · Orthopedic stereotaxic instrument
  1 recall0 reports

Product lines

• EXCELSIUS GPSGlobus Medical, Inc. · 8 models · 447 reports · 4 recalls

Other devices under the same FDA submission

3 devices cleared under K200047 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• EXCELSIUS GPS 6143.1834S

  Globus Medical, Inc. · Orthopedic stereotaxic instrument
  1 recall0 reports
• EXCELSIUS GPS 6143.1870S

  Globus Medical, Inc. · Neurological stereotaxic Instrument
  1 recall0 reports
• EXCELSIUS GPS 6143.2505

  Globus Medical, Inc. · Neurological stereotaxic Instrument
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 93742).

• Z-0995-2024 · 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
• Z-0997-2024 · Open, Classified
  Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S