DJO SURGICAL 300-02-045Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912113380), received between Dec 23, 2019 and Dec 26, 2019 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (K022437); 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.

• InjuryDec 26, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO CONVERTING TO TOTAL KNEE.

  Patient problems: No Code Available

  MAUDE report 9519927 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - CONVERSION OF TOTAL KNEE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9511004 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022437. 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.