DJO SURGICAL 346-12-705Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00190446269847), received between Oct 26, 2022 and Dec 19, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  PT SHOW SIGNS OF SUBLUXATION, NEEDED MORE CONSTRAINT.

  Patient problems: Joint Dislocation

  MAUDE report 23858021 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT NEEDED CLEANING OF KNEE AND NEW POLY.

  Patient problems: Insufficient Information

  MAUDE report 22487406 ↗
• InjuryJan 23, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 21221463 ↗
• InjuryOct 14, 2024Adverse 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 20447376 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO PATELLAR TENDON REPAIR. POLY REMOVED FOR SPACE TO REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 19397977 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT FELL AND LIGAMENTS LOOSENED SO THEY NEEDED A MORE STABILIZING POLY FOR THEIR KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 15675042 ↗

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