DJO SURGICAL 346-16-703Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190446219064), received between Nov 17, 2022 and Nov 17, 2022 — classified as 1 injury.

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

• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT WAS STILL UNSTABLE AFTER FIRST REVISION BECAUSE OF TORN MEDIAL COLLATERAL LIGAMENT. REVISED AGAIN FOR INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 15814310 ↗

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