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Recall Observatory FDA recall evidence

Device product

MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.

Z-0762-2025

December 02, 2024

Class II

Product summary

Firm
Moximed, Inc.
Event
Event 95887
Status
Ongoing
Classification
Class II
Quantity
115
Official record key
device-enforcement:Z-0762-2025

Official wording

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.

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).

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.