MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Summary
The FDA issued a Class II for MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant by Moximed, Inc.. 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 compone.
Details
Source
Device Recall
External ID
Z-0762-2025
Action Date
2025-01-01
Status
Ongoing
Category
device
Product Description
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Lot/Code Info: 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).
Quantity Affected: 115
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
US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-02
Company
Fremont, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Moximed, Inc. has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Moximed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Moximed, Inc. have FDA actions?
Moximed, Inc. has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0762-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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