Recall Z-1038-2026 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Medicrea International
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
| Date | Jan 9, 2026 (initiated Oct 29, 2025) |
| Status | Open, Classified |
| Reason | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. |
| Root cause | Under Investigation by firm |
| Action | On October 29, 2025, Medtronic issued a Urgent: Medical Device Recall Notification via UPS. Medtronic ask consignees to take the following actions: 1. Immediately identify and quarantine the potentially affected product and instruments set identified in the table above. 2. Your local Medtronic Spine Representative will be contacting you to coordinate the return of potentially affected products and instruments sets. 3. Complete and return the Customer Confirmation Form, even if you do not have any affected product. Please complete all fields, sign the form, and email neuro.quality@medtronic. |
| Quantity | 44 units |
| Distribution | US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241164 | IB3D PL Spinal System Medicrea International S.A.S. (Medtronic), Sep 6, 2024 |