Recall Z-0642-2024— Globus Medical, Inc.
Class I · Ongoing
Class I FDA medical device recall by Globus Medical, Inc., initiated 2023-12-07. It names one FDA 510(k) clearance: K211616. Product: ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100. 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..
- Recalling firm
- Globus Medical, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-12-07
- Firm location
- Audubon, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.