IMPIX TLIF — Class II medical device recall Z-2457-2023
Ongoing recall by Medicrea International, reported 2023-08-30, distributed nationwide. There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the in
| Recall number | Z-2457-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medicrea International, Rillieux La Pape, N/A, France |
| Recall initiated | 2023-07-12 |
| Classified | 2023-08-24 |
| Reported by FDA | 2023-08-30 |
| Distributed | Nationwide (US) |
| Quantity | 730 units |
| UPC / GTIN / UDI-DI | 03613720193760, 03613720193784, 03613720193807, 03613720245674, 03613720245681, 03613720275572, 03613720275589, 03613720275596, 03613720275602, 03613720275619, 03613720275626 |
| Lot numbers | 18D1077, 18G0602, 18I0594, 19A0329R, 19A0336R, 19A0337R, 19A0338R, 19A0339R, 19A0340R, 19B0894, 19B0895, 19C0091, 19C0092, 19D0071, 19E0170, 19F0641, 19G0337, 19G0921, 19G0922, 19I0695, 19J0324, 19J0690, 19L0032, 19L0045, 20A0042, 20A0228, 20A0423, 20A1000, 20B0320, 20B0322, 20B0476, 20B0477, 20B0478, 20B0479, 20B0731, 20B0732, 20F0908, 20F0909, 20H0481, 20I0097 and 2 more |
Product
IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar
Reason for recall
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
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-2457-2023. 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.