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Moximed, Inc. recalls MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Recalled January 1, 2025 · FDA recall Z-0762-2025 · Moximed
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. · FDA Class II
Units
115
Sold at
US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.
Description
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.
Product
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Manufacturer(s)
Moximed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →