The Recall Desk
HighFDA (Devices)·Z-0762-2025·Announced 2025-01-01

MISHA Knee System Implants recalled due to fracture risk

Moximed is recalling 115 MISHA Knee System Implants in multiple US states due to a supplier component defect that may cause the implant to fracture, potentially leading to pain, swelling, and stiffness.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a structural medical device defect with potential for fracture and related patient symptoms. No illnesses or injuries have been reported to date, meeting the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Moximed, Inc. is recalling MISHA Knee System Implant Small units (both left and right) distributed in California, Oregon, New York, Ohio, Texas, Colorado, and Virginia. A total of 115 implants are affected.

The recall was initiated due to a supplier-related issue in a component that has nonconforming geometry at the distal end of the absorber component. This defect may result in reduced wall thickness and microcracks in the implant.

If the implant fractures, patients may experience new or worsening symptoms including discomfort, swelling, pain, or stiffness. Depending on the severity, the implant may need to be surgically removed.

The recalled product

Product
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Manufacturer
Moximed, Inc.
Category
Medical Device — Orthopedic / Knee Implant
Hazard
  • implant-fracture
  • structural-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • 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).

Distribution

Distributed nationwide across the United States.

Related recalls

Same category