IMPIX DLIF — Class II medical device recall Z-2455-2023
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-2455-2023 |
|---|---|
| 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 | 24 units |
| UPC / GTIN / UDI-DI | 03613720196341, 03613720196358, 03613720196396, 03613720196419, 03613720196440, 03613720196457, 03613720196464, 03613720196495, 03613720196518, 03613720196594, 03613720196617 |
| Lot numbers | 18C0626, 18C0629, 18F1034, 18G0178, 19F0713, 19F0715, 19F0716, 19G0068, 19K0269, 19K0270, 20B0490 |
Product
IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; 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-2455-2023. 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.