DJO SURGICAL 346-19-707Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190446219262), received between Jul 11, 2019 and Aug 29, 2025 — classified as 3 injuries.

1 other recall cover devices cleared under the same FDA submission (K180930); 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.

• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22929623 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO POLY SWAP. WASHOUT AND I & D.

  Patient problems: Insufficient Information

  MAUDE report 19397976 ↗
• InjuryJul 11, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE PATIENT WAS INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 8783258 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180930. One submission often covers many models, so check the product and lot details in each record.

• Z-1187-2023 · Dec 22, 2022 · Open, Classified
  EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22