GRANVIA-C — Class II medical device recall Z-2459-2023
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-2459-2023 |
|---|---|
| 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 | 03613720192602, 03613720192619, 03613720192626, 03613720192633, 03613720192664, 03613720192671, 03613720192688, 03613720192718, 03613720192725, 03613720192732, 03613720235637, 03613720235651, 03613720235668, 03613720235682, 03613720235699, 03613720235705 |
| Lot numbers | 18A0891, 18A0892, 18B1066, 18B1067, 18D0593, 18D0594, 18E0614, 18F0191, 18F1031, 18H0671, 18J0465, 18J0466, 18J0704, 18J0705, 18J0706, 18J0707, 18J0709, 18J0710, 18J0711, 18K0878, 18L0331, 18L0389, 18L0390, 19A0354, 19A0355, 19A0356, 19A0377, 19A0658, 19B0304, 19B0305, 19B0394, 19B0395, 19B0915, 19C0241, 19C0394, 19C0759, 19D0306, 19D0307, 19D0379, 19D0380 and 65 more |
Product
GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿¿¿¿¿ B13111016, j)¿¿¿¿¿¿ B13111017, k)¿¿¿¿¿ B13111025, l)¿¿¿¿¿¿ B13111026, m)¿¿¿ B13111027, n)¿¿¿¿ B13111034, o)¿¿¿¿ B13111035, p)¿¿¿¿ B13111036; 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-2459-2023. 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.