# FDA recall Z-1091-2019

> **Integra Limited** · Class II · device recall initiated 2019-03-01.

## Product

Integra bioBLOCK Resorbable subtaler Implant, 12mm  Catalog Number: 040012 - Product Usage:   The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.

## Reason for recall

Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F

## Distribution

US Nationwide distribution in the states of OH, MI.

## Key facts

- **Recall number:** Z-1091-2019
- **Recalling firm:** Integra Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-01
- **Report date:** 2019-04-17
- **Termination date:** 2020-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plainsboro, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1091-2019

## Citation

> AI Analytics. FDA recall Z-1091-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1091-2019. Source: US FDA. Licensed CC0.

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