# FDA recall Z-2459-2023

> **Medicrea International** · Class II · device recall initiated 2023-07-12.

## 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 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.

## Distribution

US nationwide

## Key facts

- **Recall number:** Z-2459-2023
- **Recalling firm:** Medicrea International
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-12
- **Report date:** 2023-08-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rillieux La Pape, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2459-2023

## Citation

> AI Analytics. FDA recall Z-2459-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2459-2023. Source: US FDA. Licensed CC0.

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