Pedicle Screws — Class II medical device recall Z-1472-2020
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-1472-2020 |
|---|---|
| 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 | 19B0847, 19B0847R, 19B0848, 19B0848R, 19B0849, 19B0849R, 19B0851, 19B0851R, 19B0852, 19B0852R, 19B0853, 19B0853R, 19B0854, 19B0854R, 19C0269, 19C0269R, 19C0270, 19C0270R, 19C0271, 19C0271R, 19C0272, 19C0272R, 19C0273, 19C0273R, 19C0274, 19C0274R, 19C0275, 19C0275R, 19C0638, 19C0639, 19C0640, 19C0641, 19C0642, 19C0643, 19C0644, 19C0645, 19C0646, 19C0647, 19C0648, 19C0649 and 100 more |
Product
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560 B36007535 B36007540 B36007545 B36007550 B36007555 B36007560 B36008535 B36008540 B36008545 B36008550 B36008555 B36008560 B36009535 B36009540 B36009545 B36009550 B36009555 B36009560 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-1472-2020. 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.