Omnifit 6070-0935ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327023459), received between Jan 16, 2022 and Jan 16, 2022 — 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.

• InjuryJan 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  51MM BIPOLAR, 28MM +0 C TAPER COCR HEAD, AND 9/132 OMNIFIT HFX PRESSFIT APPLICATION STEM WERE USED IN A HEMIARTHROPLASTY ON (B)(6) 2021. ON TUESDAY 12/21/21 I WAS CONTACTED BY DR, WHO DID THE HEMI, INDICATING THE PATIENT DISLOCATED, AND WE WOULD BE REVISING THE CASE. A 51MM BIPOLAR, 28 +5 COCR C TAPER HEAD, AND 7/132 OMNIFIT EON CEMENTED STEM WAS IMPLANTED ON (B)(6) 2021, ALL IMPLANTS FROM THE PRIMARY HEMI WERE EXPLANTED. THEY ARE NOT AVAILABLE FOR RETURN AS PER HOSPITAL POLICY.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 13262663 ↗

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