# FDA recall Z-2458-2023

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

## Product

PASS LP, REF numbers:    a) B02315535Z,   b) B02315540Z,   c) B02315545Z,   d) B02315550Z,   e) B02316535Z,   f) B02316540Z,   g) B02316545Z,   h) B02316550Z,   i) B02317540Z,   j) B02317545Z,   k) B02317550Z; 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-2458-2023
- **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-2458-2023

## Citation

> AI Analytics. FDA recall Z-2458-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2458-2023. Source: US FDA. Licensed CC0.

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