Endo-Model Standard Knee Prosthesis System 15-0027/16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575432134), received between Jul 25, 2023 and Aug 4, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Expiration Date Error” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 6, 2026Class IIOpen, Classified

   The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.

   Z-2934-2026 · Root cause: Process change control · Recall details · FDA record ↗

2. Jan 12, 2026Class IIOpen, Classified

   The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

   Z-1523-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2023Expiration Date Error; Expiration Date Error

  DISTRIBUTOR WAS NOTIFIED BY SALES REP THAT A POLY PLATEAU WITH AN EXPIRED DATE OF 03/2023 WAS IMPLANTED ON (B)(6) 2023. THE IMPLANT WAS REMOVED PRIOR TO CLOSING AND REPLACED. [CUSTOMER]

  Patient problems: Insufficient Information

  MAUDE report 17457771 ↗
• InjuryJul 25, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  LINKBIO WAS NOTIFIED BY THE REPRESENTATIVE FROM EARHARDT MEDICAL THAT A POLY PLATEAU WITH AN EXPIRED DATE OF 03/2023 WAS IMPLANTED ON (B)(6), 2023. THE IMPLANT WAS REMOVED PRIOR TO CLOSING AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390847 ↗