FDA Medical devices recall ·
MISHA Knee System Implant Small, Left recall
- Recall number
- Z-0762-2025
- Date
- (initiated December 2, 2024)
- Company / brand
- Moximed, Inc.
46602 Landing Pkwy, Fremont, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 115
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF/UDI-DI/Lot(Expiration): 2-1001/00856047005795/23032901(29-Mar-25), 23092102(21-Sep-25), 24032601(26-Mar-26). 2-1002/00856047005801/23032902(29-Mar-25), 23092503(25-Sep-25), 24040801(8-Apr-26).
Distribution
US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.
States: California Colorado New York Ohio Oregon Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0762-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.