FDA Medical Device Recalls (openFDA)
Globus Medical, Inc.: ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
- Recall number
- Z-0642-2024
- Recalling firm
- Globus Medical, Inc.
- Product
- ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
- Status
- Open, Classified
- Initiated
- 2023-12-07
- Posted
- 2024-01-18
- Terminated
- not on file
- 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.
- Root cause
- Device Design
- Action
- The firm notified affected customers through URGENT Medical Device Recall Notificatnoi letters dated December 7, 2023. Customers are instructed to immediately return the Flat Panel Fluoroscopy Registration Fixture. For questions related to this recall, please contact Globus Medical Complaint Handling Unit at recall@globusmedical.com.
- Quantity
- 9
- Distribution
- Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
- Lot, serial or model codes
- UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109
- 510(k) numbers
- ["K211616"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3004142400
- Firm city
- Audubon
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28