Globus Medical Cannula May Not Be Properly Sterilized
Some ExcelsiusGPS Cannulas have an internal gap that prevents proper sterilization, increasing infection risk. Globus Medical is recalling 570 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a sterility failure on a surgical instrument. The inability to properly sterilize a device creates significant risk of infection and cross-contamination during surgical procedures, meeting the criterion for High severity.
Plain-English summary
Globus Medical, Inc. is recalling the ExcelsiusGPS Cannula A (9mm x 250mm, Model No. 6143.2844), a surgical instrument used with ball tip probes. The device may contain an internal gap that makes it difficult or impossible to clean properly before steam sterilization, leaving residual material that compromises sterility.
Devices that cannot be rendered sterile pose an increased risk of infection, inflammation, local toxicity, systemic toxicity, sensitivity reactions, and cross-contamination during surgical use.
Approximately 570 units have been distributed worldwide, including throughout the United States and to Australia, Austria, Belgium, Czech Republic, Germany, India, Indonesia, Ireland, Italy, Japan, Malaysia, Netherlands, Poland, Saudi Arabia, Singapore, Spain, United Arab Emirates, and United Kingdom. Affected lot numbers include FSB136AA, FSB121AA, FSB241AA, FSB207AA, FSB110AA, FSB073AA, and multiple additional FSA, FSY, FSX, and FSW lot codes.
Healthcare providers and patients should not use affected units. Contact Globus Medical, Inc. for instructions on device return or replacement.
The recalled product
- Product
- ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
- Manufacturer
- Globus Medical, Inc.
- Affected units
- 570
Distribution
Distributed nationwide across the United States.
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