# FDA recall Z-0479-2026

> **Miach Orthopaedics** · Class II · device recall initiated 2023-02-02.

## Product

BEAR Implant (Bridge-Enhanced ACL Restoration);  Model/Catalog: 1000;

## Reason for recall

The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0479-2026
- **Recalling firm:** Miach Orthopaedics
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-02
- **Report date:** 2025-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Westborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0479-2026

## Citation

> AI Analytics. FDA recall Z-0479-2026. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-0479-2026. Source: US FDA. Licensed CC0.

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