Recall archive / FDA device enforcement
GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f... — FDA record Z-2459-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 12, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Medicrea International
- Quantity
- O (US)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2459-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, 20J0514; l)¿¿¿¿¿¿ B13111026, GTIN 03613720192671, Lot Numbers: 18J0707, 20J0516, 21I0072; m)¿¿¿ B13111027, GTIN 03613720192688, Lot Numbers: 18J0709, 21A0575, 21I0126; n)¿¿¿¿ B13111034, GTIN 03613720192718, Lot Numbers: 18B1066, 18D0594, 18E0614, 18H0671, 18K0878, 18L0389, 19A0354, 19A0377, 19D0306, 19D0307, 19D0578, 19E0387, 19J0465, 19K0068, 19L0607, 20B0744, 20G0354, 20K0399, 21A0203, 21A0732, 21F0153; o)¿¿¿¿ B13111035, GTIN 03613720192725, Lot Numbers: 18A0892, 18J0465, 18J0710, 19A0355, 19B0304, 19B0394, 19B0395, 19D0579, 19F0100R, 19J0466, 19K0069, 19L0394, 20B0745, 20C0296, 20G0355, 20I0348, 20K0434, 21A0103; p)¿¿¿¿ B13111036, GTIN 03613720192732, Lot Numbers: 18B1067, 18F1031, 18J0466, 18J0711, 18L0390, 19A0356, 19B0915, 19D0581, 19G0690, 19K0157, 19L0804, 20E0256, 20I0349, 20J0512, 21A0104 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US nationwide
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 30, 2023
- Recall initiation date
- Jul 12, 2023
- Center classification date
- Aug 24, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.