# FDA recall Z-2452-2023

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

## Product

IMPIX 3D, REF numbers:     a)	B242C09122810,   b)	B242C10062810,   c)	B242C10122810,   d)	B242C11062810,   e)	B242C11122810,   f)	B242C12062810,   g)	B242C12122810,   h)	B242C12123310,   i)	B242C13062810,   j)	B242C13122810,   k)	B242C14122810,   l)	B242C15122810,   m)	B247C07062410,   n)	B247C07062810,   o)	B247C07063210,   p)	B247C08062410,   q)	B247C08062810,   r)	B247C08063210,   s)	B247C09062410,   t)	B247C09062810,   u)	B247C09063210,   v)	B247C10062410,   w)	B247C10062810,   x)	B247C10063210,   y)	B247C11062410,   z)	B247C11062810,   aa)	B247C11063210,   bb)	B247C12062410,   cc)	B247C12062810,   dd)	B247C12063210,   ee)	B247C13062410,   ff)	B247C13062810,   gg)	B247C13063210,   hh)	B247C14062410,   ii)	B247C14062810,   jj)	B247C14063210,   kk)	B247C15062810,   ll)	B247C15063210;  intervertebral fusion device - lumbar

## 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-2452-2023
- **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-2452-2023

## Citation

> AI Analytics. FDA recall Z-2452-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2452-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*