DJO SURGICAL 340-45-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912116152), received between Mar 23, 2018 and Jun 28, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Contamination” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2018Appropriate Device Problem Term/Code Not Available

  SECOND REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION AND NEEDING A POLY SWAP.

  Patient problems: Unspecified Infection

  MAUDE report 7648418 ↗
• InjuryMar 23, 2018Contamination

  REVISION SURGERY - DUE TO THE PATIENT HAVING DEVELOPED AN INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7365848 ↗

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.