FDA Device recall Z-2459-2023
GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿…
- FDA Device
- Class II
- ongoing
- Published 2023-08-30
On 2023-08-30 the FDA classified a Class II recall of GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿… by Medicrea International, citing there is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2459-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-12 |
| Published | 2023-08-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medicrea International |
| Distribution | US |
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
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Identifiers
| code_info | a)¿¿¿¿¿ A13111427, GTIN 03613720235637, Lot Numbers: 19D0379, 19J0745, 20F0921; b)¿¿¿¿ A13112567, GTIN 03613720235651…a)¿¿¿¿¿ A13111427, GTIN 03613720235637, Lot Numbers: 19D0379, 19J0745, 20F0921; b)¿¿¿¿ A13112567, GTIN 03613720235651, Lot Numbers: 18F0191, 19D0380; c)¿¿¿¿¿ A13113456, GTIN 03613720235668. Lot Numbers: 19C0241, 20F0929; d)¿¿¿¿ A13131516, GTIN 03613720235682, Lot Numbers: 21A0438; e)¿¿¿¿ A13131789, GTIN 03613720235699, Lot Numbers: 21D0856; f)¿¿¿¿¿¿ A13132012, GTIN 03613720235705, Lot Numbers: 21D0857; g)¿¿¿¿¿ B13111014, GTIN 03613720192602, Lot Numbers: 18J0704, 19I0437, 19L0317, 20B0743, 20H0170, 20I0346; h)¿¿¿¿ B13111015, GTIN 03613720192619, Lot Numbers: 18A0891, 18L0331, 19B0305, 19D0744, 19G0689, 19I0840, 19K0222, 20A0967, 20B0167, 20I0201, 20J0513, 21A0098,; i)¿¿¿¿¿¿ B13111016, GTIN 03613720192626, Lot Numbers: 18J0705, 19C0759, 19I0435, 19L0103, 20G0353, 20K0398, 21A0099, 21A0574, 21F0151; j)¿¿¿¿¿¿ B13111017, GTIN 03613720192633, Lot Numbers: 18J0706, 21D0097, 21I0125; k)¿¿¿¿¿ B13111025, GTIN 03613720192664, Lot Numbers: 18D0593, 19A0658, 19C0394, 19K0343, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2459-2023%22
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