FDA Device recall Z-1038-2026
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
- FDA Device
- Class II
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class II recall of Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 by Medicrea International, citing due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1038-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-29 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medicrea International |
| Distribution | US |
Product
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Reason
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Identifiers
| code_info | Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1038-2026%22
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