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

Recall date

December 2, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0762-2025

FDA classification

Class II

Brand / firm

Moximed, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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