FDA-Device2025-01-01Class II
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Moximed, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.
Affected count
115
Manufactured in
46602 Landing Pkwy, Fremont, CA, United States
Products
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0762-2025Don't want to check this manually?
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