MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
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.
US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0762-2025