Globus Medical, Inc.
6 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Globus Medical, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-04-30FDA-DeviceClass IIMAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
- 2024-02-14FDA-DeviceClass IIExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, systemic toxicity, sensitivity, and cross-contamination.
- 2024-02-14FDA-DeviceClass IIGlobus 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.
- 2024-02-14FDA-DeviceClass IIGlobus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
- 2024-02-14FDA-DeviceClass IIGlobus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
- 2024-01-24FDA-DeviceClass IExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.
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