DJO SURGICAL 346-10-711Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190446269786), received between Jul 18, 2019 and Mar 12, 2022 — 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.

• InjuryMar 12, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13743633 ↗
• InjuryJan 20, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY : DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13311669 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY -PATIENT FELL AND THE INCISION OPENED.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 8804667 ↗

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