DJO SURGICAL 340-40-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912116022), received between Apr 5, 2016 and Jul 27, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K020741); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Unstable; Adverse Event Without Identified Device or Use Problem

  Revision Surgery - Due to Pain and Instability.

  Patient problems: Joint Laxity; Pain

  MAUDE report 50010815 ↗
• InjuryMar 5, 2020Naturally Worn

  REVISION SURGERY - REVISION FOR EXCESSIVE WEAR.

  Patient problems: No Code Available

  MAUDE report 9794015 ↗
• InjuryFeb 27, 2020Naturally Worn; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - REVISION FOR EXCESSIVE WEAR.

  Patient problems: No Information

  MAUDE report 9764215 ↗
• InjuryFeb 27, 2020Naturally Worn; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - REVISION FOR EXCESSIVE WEAR.

  Patient problems: No Information

  MAUDE report 9764208 ↗
• InjuryApr 5, 2016Connection Problem

  PRIMARY SURGERY - THE INSERT WOULD NOT SNAP IN AFTER 20 MINUTES; NEW OWN SNAPPED IN RIGHT AWAY.

  Patient problems: No Information

  MAUDE report 5548175 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020741. One submission often covers many models, so check the product and lot details in each record.

• Z-0010-2008 · Aug 9, 2007 · Terminated
  EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
• Z-0009-2008 · Aug 9, 2007 · Terminated
  EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.