MISHA Knee System Implant Small — Class II medical device recall Z-0762-2025
Ongoing recall by Moximed, Inc., reported 2025-01-01, distributed nationwide. Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry a
| Recall number | Z-0762-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Moximed, Inc., Fremont, CA, United States |
| Recall initiated | 2024-12-02 |
| Classified | 2024-12-23 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Quantity | 115 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00856047005795, 00856047005801 |
| Model numbers | 2-1001, 2-1002 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0762-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.