FDA Device recall Z-0762-2025
MISHA Knee System Implant Small, Left, REF: 2-1001
- FDA Device
- Class II
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of MISHA Knee System Implant Small, Left, REF: 2-1001 by Moximed, citing 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 reduc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0762-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-02 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Moximed |
| Distribution | US |
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.
Identifiers
| code_info | REF/UDI-DI/Lot(Expiration): 2-1001/00856047005795/23032901(29-Mar-25), 23092102(21-Sep-25), 24032601(26-Mar-26). 2-100…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). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0762-2025%22
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