Home / Recalls / Moximed, Inc. / Z-0762-2025

Z-0762-2025 Class II Ongoing

Recalled by Moximed, Inc. — Fremont, CA

Recall Details

Product Type: Devices
Report Date: January 1, 2025
Initiation Date: December 2, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 115

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.

Distribution Pattern

US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.

Code Information

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).