Omnifit 6070-1035ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327023442), received between Sep 1, 2022 and Sep 1, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 1, 2022Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED A PRIMARY SURGERY ON (B)(6) 2019 AND REPORTED SEVERE PAIN SINCE. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL.

  Patient problems: Fall; Inadequate Osseointegration; Pain

  MAUDE report 15342530 ↗

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