Class II — Moximed, Inc.
| Recalling firm | Moximed, Inc. |
|---|---|
| Registered facility | MOXIMED, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002. |
| Quantity | 115 |
| Distribution | US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA. |
| Initiated | 2024-12-02 |
| Classified | 2024-12-23 |
| Recall number | Z-0762-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Moximed, Inc. (Z-0762-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95887/
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