Recall Z-0642-2024 ยท OLO Orthopedic Stereotaxic Instrument
Globus Medical, Inc.
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
| Date | Jan 18, 2024 (initiated Dec 7, 2023) |
| Status | Open, Classified |
| Reason | A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement. |
| Root cause | Device Design |
| Action | The firm notified affected customers through URGENT Medical Device Recall Notificatnoi letters dated December 7, 2023. Customers are instructed to immediately return the Flat Panel Fluoroscopy Registration Fixture. For questions related to this recall, please contact Globus Medical Complaint Handling Unit at recall@globusmedical.com. |
| Quantity | 9 |
| Distribution | Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211616 | ExcelsiusHub Globus Medical, Inc., Aug 25, 2021 |