Moximed MISHA Knee System Implants Recalled for Potential Component Fracture

Agency Publication Date: December 23, 2024

Summary

Moximed, Inc. is recalling 115 units of the MISHA Knee System Implant Small (Left and Right models) because a manufacturing issue with the absorber component may cause it to fracture. A supplier error resulted in thin walls and microcracks in the component's geometry, which could lead to worsening pain, swelling, and stiffness for patients. If the implant fractures, it may require a surgical procedure to remove or replace the device.

Risk

The absorber component of the knee implant may fracture due to reduced wall thickness and microcracks. This failure can cause new or worsening symptoms such as pain, edema, and joint stiffness, potentially necessitating surgical revision to remove the faulty implant.

What You Should Do

This recall involves the MISHA Knee System Implant Small, specifically Left models (REF 2-1001) and Right models (REF 2-1002).
For the Left implant (REF 2-1001), check for lot numbers 23032901 (Exp 29-Mar-25), 23092102 (Exp 21-Sep-25), or 24032601 (Exp 26-Mar-26).
For the Right implant (REF 2-1002), check for lot numbers 23032902 (Exp 29-Mar-25), 23092503 (Exp 25-Sep-25), or 24040801 (Exp 8-Apr-26).
Stop using the recalled device. Contact the manufacturer or your distributor immediately to arrange for the return, replacement, or correction of any affected units in your inventory.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MISHA Knee System Implant Small, Left

Variants: Small, Left

Model / REF:

2-1001

Lot Numbers:

23032901 (Exp 29-Mar-25)

23092102 (Exp 21-Sep-25)

24032601 (Exp 26-Mar-26)

UDI:

00856047005795

Quantity affected for both Left and Right models combined is 115.

Product: MISHA Knee System Implant Small, Right

Variants: Small, Right

Model / REF:

2-1002

Lot Numbers:

23032902 (Exp 29-Mar-25)

23092503 (Exp 25-Sep-25)

24040801 (Exp 8-Apr-26)

UDI:

00856047005801

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95887

Status: Active

Manufacturer: Moximed, Inc.

Sold By: Hospitals; Orthopedic surgical centers

Manufactured In: United States

Units Affected: 115

Distributed To: California, Oregon, New York, Ohio, Texas, Colorado, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves the MISHA Knee System Implant Small, specifically Left models (REF 2-1001) and Right models (REF 2-1002).

For the Left implant (REF 2-1001), check for lot numbers 23032901 (Exp 29-Mar-25), 23092102 (Exp 21-Sep-25), or 24032601 (Exp 26-Mar-26).

For the Right implant (REF 2-1002), check for lot numbers 23032902 (Exp 29-Mar-25), 23092503 (Exp 25-Sep-25), or 24040801 (Exp 8-Apr-26).

Stop using the recalled device. Contact the manufacturer or your distributor immediately to arrange for the return, replacement, or correction of any affected units in your inventory.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this recall.

Affected Products

Product: MISHA Knee System Implant Small, Left

Variants: Small, Left

Model / REF:

2-1001

Lot Numbers:

23032901 (Exp 29-Mar-25)

23092102 (Exp 21-Sep-25)

24032601 (Exp 26-Mar-26)

UDI:

00856047005795

Quantity affected for both Left and Right models combined is 115.

Product: MISHA Knee System Implant Small, Right

Variants: Small, Right

Model / REF:

2-1002

Lot Numbers:

23032902 (Exp 29-Mar-25)

23092503 (Exp 25-Sep-25)

24040801 (Exp 8-Apr-26)

UDI:

00856047005801