LINK Endo-Model EVO Knee System 15-8541/10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575223657), received between Feb 3, 2026 and Feb 9, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

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.

• InjuryFeb 9, 2026Detachment of Device or Device Component

  NOTIFIED BY REPRESENTATIVE (B)(6) THAT A SURGERY WAS PERFORMED ON (B)(6) 2025 USING AN ENDO EVO W WITH AN OPTISTEM ADAPTOR, AND IT BECAME DISASSOCIATED A FEW WEEKS LATER AND HAD TO BE REVISED. THE REPRESENTATIVE STATED THAT WHEN THE REVISION OF THE COMPONENTS TOOK PLACE, THEY NOTICED THAT THE SET SCREW WAS NOT USED IN THE FEMORAL COMPONENT AND OPTISTEM ADAPTOR JUNCTION. A REVISION OCCURRED ON (B)(6) 2025 WITHOUT ANY ISSUES WHEN THE SET SCREW WAS USED. [CUSTOMER].

  Patient problems: Insufficient Information

  MAUDE report 24289896 ↗
• InjuryFeb 3, 2026Improper or Incorrect Procedure or Method

  NOTIFED BY REPRESENTATIVE (B)(6) THAT A SURGERY WAS PERFORMED ON (B)(6) 2025 USING AN ENDO EVO W WITH AN OPTISTEM ADAPTOR, AND IT BECAME DISASSOCIATED A FEW WEEKS LATER AND HAD TO BE REVISED. THE REPRESENTATIVE STATED THAT WHEN THE REVISION OF THE COMPONENTS TOOK PLACE, THEY NOTICED THAT THE SET SCREW WAS NOT USED IN THE FEMORAL COMPONENT AND OPTISTEM ADAPTOR JUNCTION. A REVISION OCCURRED ON (B)(6) 2025 WITHOUT ANY ISSUES WHEN THE SET SCREW WAS USED.

  Patient problems: Joint Laxity

  MAUDE report 24250411 ↗