DJO SURGICAL 200-01-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912108928), received between Dec 2, 2022 and Dec 2, 2022 — classified as 1 injury.

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.

• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY, UNAWARE OF SYMPTOMS, COULD OF BEEN INSTABILITY OR PAIN POSSIBLY. UPON REMOVAL THE FEMORAL COMPONENT APPEARED TO BE LOOSE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15908927 ↗

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.