Omnifit 6076-0525ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327023527), received between Sep 30, 2020 and Sep 30, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K031744); 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.

• InjurySep 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. SURGEON REPORTED THERE ARE NO ALLEGATIONS AGAINST THE IMPLANTS, AND CONVERTED THE PATIENT'S HEMI HIP TO A TOTAL HIP. REP PROVIDED THE REVISION USAGE SHEET AND EXPLANT PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 10604841 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031744. One submission often covers many models, so check the product and lot details in each record.

• Z-0896-2009 · Nov 13, 2008 · Terminated
  Omnifit HFX Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or