Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0762-2025 — MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.

U.S. FDA — Device Enforcement · United States · 2024-12-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0762-2025
Date of alert
2024-12-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Moximed, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00856047005795
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.