Moximed, Inc.: Device Recall
Recall #Z-0762-2025 · 12/02/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0762-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Moximed, Inc.
- Status
- Ongoing
- Date Initiated
- 12/02/2024
- Location
- Fremont, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115
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.
Product Description
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Distribution Pattern
US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.