DJO SURGICAL 110-03-735Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190446337416), received between May 12, 2023 and Mar 11, 2025 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K212941); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 21579851 ↗
• InjuryMay 12, 2023Adverse 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 16924877 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K212941. One submission often covers many models, so check the product and lot details in each record.

• Z-1384-2023 · Feb 28, 2023 · Open, Classified
  EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108