DJO SURGICAL 243-02-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190446231417), received between Oct 10, 2019 and Jan 13, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K171991); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PAIN

  Patient problems: Pain

  MAUDE report 24063639 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO FALL LOWER BODY COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 19085554 ↗
• InjuryOct 10, 2019Loose or Intermittent Connection

  REVISION SURGERY - THE PATIENT HAD LACK OF MOTION AND PRESENTED PAIN TO SURGEON. THE FEMUR AND TIBIA BECAME LOOSE DUE TO POOR BONE GROWTH. THE SURGEON WENT WITH CEMENTED ITEMS INSTEAD OF P2 FOR THE REVISION SURGERY.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9174745 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171991. One submission often covers many models, so check the product and lot details in each record.

• Z-0508-2024 · Nov 10, 2023 · Open, Classified
  DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108
• Z-0258-2024 · Sep 29, 2023 · Open, Classified
  DJO EMPOWR Knee Punch Handle, REF: 801-05-040
• Z-0060-2021 · Aug 3, 2020 · Open, Classified
  DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conj