IMPIX C+ — Class II medical device recall Z-2460-2023
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-2460-2023 |
|---|---|
| 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 | 0 |
| UPC / GTIN / UDI-DI | 03613720234241, 03613720234258, 03613720234265, 03613720234272, 03613720234319, 03613720234326, 03613720234333, 03613720234340 |
| Lot numbers | 18C0676R, 18C0677, 18D0172, 18D0174, 18I0761, 18J0489, 18K0298, 18K0653, 18L0401, 18L0497, 18L0498, 19A0636, 19A0654, 19A0773, 19B0189, 19B0524, 19C0511, 19C0512, 19C0513, 19C0664, 19D0565, 19D0672, 19E0087, 19E0477, 19E0573, 19G1092, 19I0617, 19I0849, 19K0180, 19K0478, 19K0687, 19L0701, 20A0488, 20B0586, 20B0587, 20C0164, 20G0851, 20H0262, 20H0263, 20H0264 and 16 more |
Product
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
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-2460-2023. 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.