IMPIX 3D — Class II medical device recall Z-2452-2023
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-2452-2023 |
|---|---|
| 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 | 248 units |
| UPC / GTIN / UDI-DI | 03613720270522, 03613720270539, 03613720270546, 03613720270553, 03613720272526, 03613720272533, 03613720272540, 03613720272557, 03613720272564, 03613720272571, 03613720272588, 03613720272595, 03613720272601, 03613720272618, 03613720272625, 03613720272632, 03613720272649, 03613720272656, 03613720272663, 03613720272670, 03613720272687, 03613720272694, 03613720272700, 03613720272717, 03613720272724 and 13 more |
| Lot numbers | 18D0708, 18D0709, 18D0710, 18D0965, 18D0966, 18D0967, 18D0968, 18D0969, 18D0970, 18E0499, 18H0611R, 18H0611R/1, 18H0612, 18H0612/1, 18H0612/2, 18H0613, 18H0613/1, 18H0614, 18H0615, 18H0616/1/1, 18H0616/2, 18I0492, 18I0493, 18I0494, 18I0495, 18I0496, 18I0498, 18I0554, 18I0555, 18I0558, 18I0560, 18I0561, 18I0562, 18I0563, 18I0576, 18I0577, 18I0579, 18I0580, 18I0582, 18I0584 and 26 more |
Product
IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m) B247C07062410, n) B247C07062810, o) B247C07063210, p) B247C08062410, q) B247C08062810, r) B247C08063210, s) B247C09062410, t) B247C09062810, u) B247C09063210, v) B247C10062410, w) B247C10062810, x) B247C10063210, y) B247C11062410, z) B247C11062810, aa) B247C11063210, bb) B247C12062410, cc) B247C12062810, dd) B247C12063210, ee) B247C13062410, ff) B247C13062810, gg) B247C13063210, hh) B247C14062410, ii) B247C14062810, jj) B247C14063210, kk) B247C15062810, ll) B247C15063210; 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-2452-2023. 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.