FDA Device recall Z-1039-2026
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
- FDA Device
- Class II
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class II recall of Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174 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-1039-2026 |
| 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 PL Instruments Set, Rx Only REF: SPS03174
Reason
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Identifiers
| code_info | Lot# 0001, 0002, 0003, 0004, 0005, 0006, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0016 ,0017 ,0018, 0020, 0021, 0024, 0025, 0026, 0029/UDI: SPS03174 |
|---|
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-1039-2026%22
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