ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
FDA Recall Z-1007-2024 · Posted 2024-02-07
Recalling FirmGlobus Medical, Inc.
Recall StatusOpen, Classified
Product CodeOLO
Date Initiated2023-12-15
Product Quantity570
Reason for Recall
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.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.