Class I — Globus Medical, Inc.
| Recalling firm | Globus Medical, Inc |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | 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. |
| Product | ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 |
| Quantity | 9 |
| Distribution | Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK. |
| Initiated | 2023-12-07 |
| Classified | 2024-01-18 |
| Recall number | Z-0642-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Globus Medical, Inc. (Z-0642-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93647/
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