ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Globus Medical, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Product Codes/Lot Numbers:
UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109
Distribution:
Distributed in: CA, CO, MT, SC, WA, UK
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0642-2024
Related Recalls
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Globus Medical
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.
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Globus Medical
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.
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.