EXCELSIUS GPS recallZ-1007-2024 · Globus Medical, Inc. · initiated Dec 15, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Globus Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
On December 15, 2023, the firm began to notify customers by phone. On January 9, 2024, firm began following up with letters. Customers were instructed to immediately return affected cannulas to Globus Medical and complete the letter's Response Card. For recall-related questions, please contact Globus Medical Complaint Handling Unit at [email protected]. Fax: 610-300-1342.
Recall details
- Recall number
- Z-1007-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 15, 2023
- Posted by the FDA
- Feb 7, 2024
- Recalling firm
- Globus Medical, Inc.
- Quantity
- 570
- Product code
- OLO
- FDA submissions
- K171651
- Distribution
- Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Czech Republic, Germany, India, Indonesia, Ireland, Italy, Japan, Malaysia, Netherlands, Poland, Saudi Arabia, Singapore, Spain, United Arab Emirates, United Kingdom.
Product description
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Code information (models, lots, serial numbers)
UDI-DI 00889095998498 Lots FSB136AA FSB121AA FSB241AA FSB207AA FSB136AA FSB121AA FSB110AA FSB073AA FSA286CA FSA286BA FSA286AA FSA263DA FSA263EA FSA263CA FSA263AA FSA263BA FSA160AA FSA160BA FSA105BA FSA105AA FSA053AA FSY319AA FSY279BA FSY279AA FSY272AA FSY230AA FSY098AA FSY098CA FSY098BA FSY048AA FSX093AA FSX205AA FSX141BA FSX141CA FSX141AA FSX093AA FSX063AA FSX041AA FSX041BA FSW142AA FSW094AA
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EXCELSIUS GPS 6143.2844Globus Medical, Inc. · Orthopedic stereotaxic instrument1 recall0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K171651 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- EXCELSIUS GPS 6143.1001Globus Medical, Inc. · Orthopedic stereotaxic instrument1 death444 reports
- EXCELSIUS GPS 6143.2692Globus Medical, Inc. · Orthopedic stereotaxic instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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