DJO SURGICAL 354-10-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190446263906), received between Jun 10, 2023 and Jun 10, 2023 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K173723); 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.

• InjuryJun 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO LOOSENING.

  Patient problems: Joint Laxity

  MAUDE report 17102213 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173723. One submission often covers many models, so check the product and lot details in each record.

• Z-2603-2023 · Aug 4, 2023 · Open, Classified
  DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106