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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medicrea International
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2459-2023
Related Recalls
Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
Medicrea International
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
Medicrea International
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.