Reported Jan 1, 2025 · Ongoing
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Moximed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Moximed, Inc. · 46602 Landing Pkwy · Fremont, CA · 94538-6420
Is this the product you have?
- MISHA Knee System Implant Small, Left
- REF2-1001. MISHA Knee System Implant Small, Right
- REF2-1002
- Lot codes and dates
- 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)
- Amount recalled
- 115
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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