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MISHA Knee System Implant Small, Left, REF: 2-1001 recallZ-0762-2025 · Moximed, Inc. · initiated Dec 2, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Moximed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 12/2/2034, recall notices were sent to customers who were asked to do the following: Recipients of implants from the Affected Lots can continue to use their implant as usual. However, you should evaluate patients who present with any new or worsening symptoms of discomfort, swelling / edema, pain or stiffness. If a device issue is suspected or you or your patient is concerned, X-rays may be useful to evaluate the device. Decisions about removing the device should be made on a case-by-case basis between health care providers and patient or caregiver. For patients who are identified as having a fractured absorber component, the surgeon should consider explantation surgery based on their independent clinical judgment. Firm is providing surgeons with a draft letter for their patients who have been implanted with affected Knee Systems from the Affected Lots. Firm recommends that surgeons customize the letter, send it to patients implanted with affected devices, and discuss with patients as appropriate. Share this Notice with all device users within your facility and network to ensure they are aware of this recall. This notification should also be shared with any organization if the care of patients with potentially affected devices has been transferred. Firm is prepared to assist patients with certain out-of-pocket costs related to this recall. Please correspond with the email address, [email protected], or call us at 877-204-2922. Complete and return the response form via email to [email protected]

Recall details

Recall number
Z-0762-2025
Status
Open, Classified
Initiated by the company
Dec 2, 2024
Posted by the FDA
Dec 23, 2024
Recalling firm
Moximed, Inc.
Quantity
115
Product code
QVV
Distribution
US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.

Product description

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

Code information (models, lots, serial numbers)

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).

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page