# FDA recall Z-2456-2023

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

## Product

IMPIX MANTA, REF numbers:    a) A20150407,   b) A20250407,   c) A20350567,   d) B20181743,   e) B20181753,   f) B20181763,   g) B20181773,   h) B20181943,   i) B20181953,   j) B20181963,   k) B20181973,   l) B20182253,   m) B20182263; 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-2456-2023
- **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-2456-2023

## Citation

> AI Analytics. FDA recall Z-2456-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2456-2023. Source: US FDA. Licensed CC0.

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