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
Reported: August 30, 2023 Initiated: July 12, 2023 #Z-2459-2023
Product 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
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.
Details
- Recalling Firm
- Medicrea International
- Units Affected
- O (US)
- Distribution
- US nationwide
- Location
- Rillieux La Pape, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Medicrea International. Units affected: O (US).
Why was this product recalled? ▼
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 30, 2023. Severity: Moderate. Recall number: Z-2459-2023.
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