Omnifit 6097-0630Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327022421), received between Apr 28, 2023 and Apr 28, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K983226); 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. How this data works · Data updated Oct 13, 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.

• InjuryApr 28, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY AND PAIN. INTRA-OPERATIVELY, THE CEMENTED STEM WAS ALSO FOUND TO BE ASEPTICALLY LOOSE. A HEMI HIP CONSTRUCT WAS REMOVED AND A TOTAL HIP CONSTRUCT IMPLANTED.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 16831683 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K983226. One submission often covers many models, so check the product and lot details in each record.

• Z-0899-2009 · Nov 13, 2008 · Terminated
  Omnifit Eon 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 revisio
• Z-0898-2009 · Nov 13, 2008 · Terminated
  Omnifit FC Cemented 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 prima