# FDA recall Z-0762-2025

> **Moximed, Inc.** · Class II · device recall initiated 2024-12-02.

## Product

MISHA Knee System Implant Small, Left, REF: 2-1001.    MISHA Knee System Implant Small, Right, REF: 2-1002.

## Reason for recall

Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device.

## Distribution

US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.

## Key facts

- **Recall number:** Z-0762-2025
- **Recalling firm:** Moximed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-02
- **Report date:** 2025-01-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fremont, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0762-2025

## Citation

> AI Analytics. FDA recall Z-0762-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0762-2025. Source: US FDA. Licensed CC0.

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