Medicrea GRANVIA-C Cervical Fusion Device Recalled for Packaging Defects
Medicrea International is recalling GRANVIA-C cervical intervertebral fusion devices due to a packaging non-conformity issue presenting as pinholes in inner or outer pouches, which could compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device recall for a surgical implant with a packaging defect that could compromise sterility. The hazard is high-risk for a surgical device, but no illnesses or injuries have been reported, so per the rubric, the maximum score is 3.
Plain-English summary
Medicrea International is recalling multiple lot numbers of the GRANVIA-C, a cervical intervertebral fusion device used in spinal surgery. The recall is prompted by a packaging non-conformity issue that presents as pinholes in either the inner or outer pouch of the device's sterile packaging.
A pinhole in the sterile pouch poses a potential risk to patients by compromising the sterility of the surgical implant. The devices may be exposed to contamination if the packaging integrity is compromised.
The affected devices were distributed nationwide in the United States. Consumers and healthcare providers who have received or used these devices should contact Medicrea International or their distributor to determine if their devices are included in the recall and to obtain guidance on next steps.
The recalled product
- 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
- Manufacturer
- Medicrea International
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Medicrea International under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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FDA (Devices) · 2023-08-30
- ModerateCervical intervertebral fusion devices recalled for packaging defect
FDA (Devices) · 2023-08-30
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