# FDA recall Z-0463-2021

> **Medicrea International** · Class II · device recall initiated 2020-10-08.

## Product

MEDICREA LIGAPASS TENSION PULLEY HANDLE XS-  intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies  Ref : A08200200

## Reason for recall

Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery  and lead to a risk of infection and re-intervention ,

## Distribution

CA  Foreign:France, Belgium

## Key facts

- **Recall number:** Z-0463-2021
- **Recalling firm:** Medicrea International
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-08
- **Report date:** 2020-11-25
- **Termination date:** 2024-05-09

- **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-0463-2021

## Citation

> AI Analytics. FDA recall Z-0463-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0463-2021. Source: US FDA. Licensed CC0.

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