IMPIX MANTA — Class II medical device recall Z-2456-2023
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-2456-2023 |
|---|---|
| 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 | 4,489 units |
| UPC / GTIN / UDI-DI | 03613720233251, 03613720233275, 03613720233305, 03613720233336, 03613720233442, 03613720233466, 03613720233497, 03613720233527, 03613720233657, 03613720233688, 03613720236016, 03613720236078, 03613720236108 |
| Lot numbers | 18E0532, 18F0803, 18I0840, 18I0841, 18J0713, 18J0714, 18K0067, 18K0068, 18K0069, 18L0399, 18L0570, 19A0225, 19A0371, 19A0372, 19A0786, 19A0787, 19A0830, 19B0752, 19C0587, 19D0100, 19D0208, 19D0381, 19D0382, 19D0383, 19D0384, 19D0745, 19E0604, 19G0205, 19J0470, 19J0471, 19J0592, 19J0594, 19J0611, 19J0711, 19J0746, 19K0588, 19K0731, 19K0853, 19K0878, 19L0612 and 46 more |
Product
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; 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-2456-2023. 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.