Omnifit S-2301C-2846Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327022810), received between Dec 20, 2021 and Mar 18, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K243784, K261624, K890197, K974685); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2024Fracture; Fracture

  PATIENT REPORTED A RIGHT HIP REVISION DUE TO LINER BREAKING. HEAD, CUP AND INSERT REVISED TO A LARGER SIZE.

  Patient problems: Insufficient Information; Subluxation

  MAUDE report 18921739 ↗
• InjuryDec 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON DECIDED HE WANTED TO REPOSITION THE SHELL, AND TO USE A SHELL THAT COULD ACCOMMODATE AN MDM LINER. UPON REDUCTION, SURGEON SAID THE STEM WAS TOO SHORT FOR THE CONSTRUCT, AND REVISED THE STEM. THE SHELL AND STEM (IMPLANTED APPROXIMATELY 20 YEARS AGO), AND HEAD AND LINER (IMPLANTED (B)(6) 2021) WERE REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 13047941 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K243784, K261624, K890197, K974685. One submission often covers many models, so check the product and lot details in each record.

• Z-3199-2026 · Jul 30, 2026 · Open, Classified
  ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEG
• Z-3201-2026 · Jul 30, 2026 · Open, Classified
  ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CO
• Z-0811-2020 · Nov 7, 2019 · Terminated
  Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254