DJO SURGICAL 341-11-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190446736097), received between Jun 3, 2026 and Jun 3, 2026 — classified as 1 injury.

17 other recalls cover devices cleared under the same FDA submission (K143242); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 25369525 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143242. One submission often covers many models, so check the product and lot details in each record.

• Z-2701-2026 · Feb 16, 2026 · Open, Classified
  Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.
• Z-2700-2026 · Feb 16, 2026 · Open, Classified
  Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplas
• Z-1459-2026 · Jan 15, 2026 · Open, Classified
  Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
• Z-1233-2026 · Jan 5, 2026 · Open, Classified
  EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
• Z-2286-2025 · Jul 9, 2025 · Open, Classified
  Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are inte
• Z-2285-2025 · Jul 9, 2025 · Open, Classified
  Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are inte
• Z-2125-2025 · Jun 2, 2025 · Open, Classified
  Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis
• Z-2126-2025 · Jun 2, 2025 · Open, Classified
  Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis
• Z-0766-2025 · Dec 18, 2024 · Open, Classified
  EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
• Z-0761-2025 · Dec 10, 2024 · Open, Classified
  EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
• Z-0102-2024 · Aug 22, 2023 · Open, Classified
  EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
• Z-0126-2023 · Aug 12, 2022 · Open, Classified
  EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
• Z-1257-2022 · May 5, 2022 · Open, Classified
  DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
• Z-2103-2021 · May 12, 2021 · Open, Classified
  DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
• Z-2104-2021 · May 12, 2021 · Open, Classified
  DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185

…and 2 more.