Device recall: ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Class I FDA enforcement event 93647. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Globus Medical, Inc. started this device recall on 7 Dec 2023. The firm address in the FDA record is in Audubon, PA. FDA put the recall in Class I. FDA event 93647 has 1 product record. The first FDA enforcement report date is 24 Jan 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
Recalling firm
Globus Medical, Inc., Audubon, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0642-2024 | ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 | 9 | Class I | Ongoing | 24 Jan 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class I
- 10%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Apr 2025 | MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; | Device | Class II | 1 |
| 15 Dec 2023 | ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844 | Device | Class II | 1 |
| 11 Dec 2023 | Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices w | Device | Class II | 3 |
| 22 Jul 2020 | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile) | Device | Class II | 22 |
| 28 Aug 2013 | Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voi | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0642-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 93647. https://recallregister.com/fda/i/93647/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
- What quantity of product is in FDA event 93647?
- The FDA record gives this quantity:
9
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 10% of the 917 device events that started in 2023 are in Class I.