Fremont, CA, United States
Moximed, Inc. recalls
1 recall recorded since 2018, most recently on 2 December 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 December 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0762-2025
- MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.