ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
FDA device recall Z-1007-2024 · posted 2024-02-07 · Open, Classified
Recall details
- Recalling firm
- Globus Medical, Inc.
- 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.
- Action taken
- 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 recall@globusmedical.com. Fax: 610-300-1342.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OLO
- Quantity affected
- 570
- 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, Sp
- Date initiated
- 2023-12-15
- Date posted
- 2024-02-07
- Location
- Audubon, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXCELSIUS GPS (K171651) | Globus Medical, Inc. | 2017-08-16 |