Omnifit 2041C-2846Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540035714), received between Sep 24, 2018 and Apr 26, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A REVISION THA, WHEN A NURSE OPENED THE PACKAGE, OUR SALES STAFF NOTICED THERE WAS NO LOCKING RING WITH THE INSERT. THE LOCKING RING HAD CAME OFF FROM THE INSERT INSIDE THE PACKAGE. THERE WAS NO SPARE (SAME SIZE) SO A SURGEON TRIED TO PUT THE RING ON THE INSERT BUT IT DID NOT FIT DUE TO LOOSE. HE DIRECT A NURSE TO OPEN 2041C-2848 AND REMOVED A RING FROM INSERT OF 2041C-2848. HE PUT IT ON THE INSERT OF 2041C-2846 AND IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812899 ↗
• MalfunctionNov 3, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING A REVISION THA, WHEN A NURSE OPENED THE PACKAGE, SHE NOTICED A DISENGAGED LOCKING WIRE. A SPARE INSERT WAS USED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745017 ↗
• InjurySep 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PER MEDICAL REVIEW, PATIENT HAD A CLOSED REDUCTION ON (B)(6) 2009 DUE TO DISLOCATION. MEDICAL REVIEW NOTES: "THE OPERATIVE REPORT STATES, "ACETABULUM MAY BE A LITTLE MORE VERTICAL THAN NORMAL".

  Patient problems: Joint Dislocation

  MAUDE report 7906982 ↗
• InjurySep 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2010 THE PATIENT COMPLAINED OF POPPING IN THE HIP AND ON (B)(6) 2010 SHE SUSTAINED A DISLOCATION, WHICH WAS TREATED WITH CLOSED REDUCTION, AND THE PLAN WAS TO INSERT A CONSTRAINED LINER." THE OPERATIVE REPORT STATES, "ACETABULUM MAY BE A LITTLE MORE VERTICAL THAN NORMAL."

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7906658 ↗
• InjurySep 24, 2018Degraded; Degraded

  PER MEDICAL REVIEW: "ON (B)(6) 2010 A REVISION OF THE RIGHT TOTAL HIP ARTHROPLASTY WITH EXCHANGE OF THE POLY INSERT AND FEMORAL HEAD WAS PERFORMED FOR A DIAGNOSIS OF POLY WEAR RIGHT HIP." MEDICAL REVIEW NOTES OPERATIVE REPORT DATED (B)(6) 2010 STATES: "ACETABULUM MAY BE A LITTLE MORE VERTICAL THAN NORMAL".

  Patient problems: Injury

  MAUDE report 7903958 ↗

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