IMPIX MANTA+ — Class II medical device recall Z-2462-2023
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-2462-2023 |
|---|---|
| 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) |
| UPC / GTIN / UDI-DI | 03613720232636, 03613720232667, 03613720232698, 03613720232728, 03613720232841, 03613720232872, 03613720232902, 03613720232933, 03613720233084, 03613720233114, 03613720233145 |
| Lot numbers | 18C0552, 18D0171, 18D1078, 18E0275, 18E0404, 18E0405, 18E0406, 18E0483, 18E0676, 18E0677, 18E0833, 18E0834, 18E0835, 18E0836, 18F0203, 18G0422, 18G0423, 18H0572, 18H0597, 18I0466, 18I0712, 18I0867, 18J0063, 18J0103, 18K0066, 18K0136, 18K0137, 18K0140, 18K0143, 18K0144, 18K0158, 18K0159, 18K0160, 18K0608, 18K0831, 18K0897, 18K0898, 18L0070, 18L0219, 18L0220 and 175 more |
Product
IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; 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-2462-2023. 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.