Omnifit 2041C-3254Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540035806), received between Jul 23, 2019 and Oct 18, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

1 FDA recall record name this device's identifier.

2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 7, 2019Terminated

   May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire

   Z-0811-2020 · Root cause: Employee error · FDA record ↗

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.

• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. AN I&D WAS PERFORMED, A COMPETITOR HEAD WAS REVISED AND A 32MM 10° SERIES II INSERT WAS EXCHANGED FOR ANOTHER ONE.

  Patient problems: Unspecified Infection

  MAUDE report 17955621 ↗
• MalfunctionJul 23, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT, DURING A REVISION THA, WHEN A NURSE OPEN THE PACKAGE, OUR SALES STAFF NOTICED NO LOCKING WIRE ON THE INSERT. A SPARE WAS USED INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817357 ↗

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-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-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