Recall Z-1007-2024 ยท OLO Orthopedic Stereotaxic Instrument
Globus Medical, Inc.
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
| Date | Feb 7, 2024 (initiated Dec 15, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| 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 recall@globusmedical.com. Fax: 610-300-1342. |
| Quantity | 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, Spain, United Arab Emirates, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171651 | EXCELSIUS GPS Globus Medical, Inc., Aug 16, 2017 |