DJO SURGICAL 300-01-045Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912113335), received between Dec 17, 2019 and Jan 10, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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.

• InjuryJan 10, 2020Insufficient Device Problem Information

  REVISION SURGERY CONVERTED TO TOTAL KNEE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9574655 ↗
• InjuryDec 17, 2019Insufficient Device Problem Information

  REVISION SURGERY - DUE TO CHANGE FROM A EPIK TO EMPOWR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9481812 ↗

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-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.
• 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.