Iliac Screws — Class II medical device recall Z-1473-2020
Terminated recall by Medicrea International, reported 2020-03-18, distributed nationwide. An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging
| Recall number | Z-1473-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medicrea International, Rillieux La Pape, France |
| Recall initiated | 2020-01-28 |
| Classified | 2020-03-11 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2023-03-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | GR, PT |
| Quantity | 3,529 |
| Lot numbers | 19D0369, 19D0370, 19D0371, 19D0372, 19D0570, 19D0571, 19D0572, 19D0573, 19D0574, 19D0575, 19D0576, 19D0577, 19D0683, 19D0684, 19D0685, 19D0686, 19G0521, 19G0522, 19G0523, 19G1071, 19G1073, 19G1075, 19G1076, 19G1077, 19G1078, 19G1079, 19H0470, 19H0473, 19H0474, 19H0475, 19J0445, 19J0867, 19J0868, 19J0869, 19L0501, 19L0502, 19L0503, 19L0525, 19L0526 |
Product
Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029590 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices.
Reason for recall
An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1473-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.