DJO SURGICAL 340-35-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912115889), received between Oct 18, 2017 and Oct 18, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Positioning Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2017Use of Device Problem; Positioning Problem

  PRIMARY SURGERY - DUE TO THE SURGEON COMPLAINING THAT BOTH TIBIAL INSERTS FAILED TO LOCK PROPERLY INTO THE BASEPLATE. HE DID NOT KNOW WHICH IMPLANT WAS THE PROBLEM, THE BASEPLATE OR THE INSERT. HE SAID THE TRIAL INSERT ALSO HAD A TOUGH TIME FULLY SEATING.

  Patient problems: No Information

  MAUDE report 6959362 ↗

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.