MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Reported: January 1, 2025 Initiated: December 2, 2024 #Z-0762-2025
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.
Details
- Recalling Firm
- Moximed, Inc.
- Units Affected
- 115
- Distribution
- US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.
- Location
- Fremont, CA
Frequently Asked Questions
What product was recalled? ▼
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.. Recalled by Moximed, Inc.. Units affected: 115.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2025. Severity: Moderate. Recall number: Z-0762-2025.
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