Recall Z-0762-2025— Moximed, Inc.
Class II · Ongoing
Class II FDA medical device recall by Moximed, Inc., initiated 2024-12-02. FDA's recall record names no specific 510(k) clearance for this event. Product: MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.. 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..
- Recalling firm
- Moximed, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-02
- Firm location
- Fremont, CA, United States
Product description
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.