Medical Device Recall: MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Moximed, Inc. · December 2, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
115
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0762-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.