Recall Z-3130-2024 ยท EQJ Bur, Ear, Nose And Throat
Medtronic Xomed, Inc.
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
| Date | Sep 12, 2024 (initiated Jul 5, 2024) |
| Status | Open, Classified |
| Reason | Product was distributed past expiration date. |
| Root cause | Under Investigation by firm |
| Action | Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its sole consignee on 07/05/2024 via in person visit. The notice explained the problem, potential risk if used, and requested the product be quarantined. |
| Quantity | 1 unit |
| Distribution | International distribution to the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.