Z-0762-2025Class II

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

Name: Z-0762-2025 MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002
Creator: Moximed, Inc.
Published: 2024-12-02
License: https://open.fda.gov/license/

Moximed, Inc. / initiated 2024-12-02 / Open, Classified / root cause: manufacturing process

FDA source

Moximed, Inc. began a recall of MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002 on 2024-12-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0762-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-02
Posted: 2024-12-23
Recalling firm: Moximed, Inc.
Product: MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Product code: QVV Medial Knee Implanted Shock Absorber
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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]
Quantity in commerce: 115
Distribution: US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0762-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0762-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-23

Product code QVV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)