DJO SURGICAL 352-02-109Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190446258063), received between Dec 30, 2020 and Dec 30, 2020 — 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.

• InjuryDec 30, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT PRESENTED WITH INFECTION SYMPTOMS. SURGEON CHOSE TO PULL THE DJO IMPLANTS OUT AND TREAT THE JOINT AS IF IT WAS INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 11095519 ↗

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