Omnifit 2041C-3250Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540035790), received between Mar 23, 2021 and Mar 13, 2023 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2023Unstable; Unstable

  PATIENT REPORTS SHE HAD A HIP REPLACEMENT INCLUDING A 32MM V40 HEAD IMPLANTED IN 2012 AND WOULD LIKE TO KNOW IF HER IMPLANTS WERE SUBJECT TO RECALL. UPDATE 15-FEB-2023: PATIENT REPORTED REVISION ON (B)(6) 2022 DUE TO INSTABILITY, "KNEE POPPING" AND DIFFICULTY WALKING.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 16535036 ↗
• InjuryNov 9, 2021Fracture; Fracture

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON (B)(6) 2020. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. *UPDATE ON 20-OCT-2021 BASED ON OP REPORTS: "[¿] DIAGNOSIS: [¿] DAMAGED FEMORAL HEAD SECONDARY TO FAILED ACETABULAR COMPONENT [¿] PROCEDURE DETAILS [¿] THERE WAS A TREMENDOUS AMOUNT OF METALLOSIS AND BLACK SYNOVIUM WITHIN THE JOINT. [¿] THE BROKEN PIECES OF PROBABLY FROM THE OLD ACETABULUM WERE IMMEDIATELY IDENTIFIED AND REMOVED ALONG WITH A FREE PIECE OF WIRE FROM THE OLD MARKER. [¿] "

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12779299 ↗
• InjuryMar 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR THE HIP REVISION. THE HIP WAS DISLOCATED POSTERIORLY. THERE WAS EXTENSIVE BLACKENED TISSUE WITHIN THE HIP JOINT ITSELF FROM TITANIUM STAINING. IT WAS OBVIOUS THAT THE POLYETHYLENE LINER HAD ROTATED OUT OF POSITION AND THE CERAMIC HEAD WAS ARTICULATING WITH THE INSIDE OF THE SOCKET. WE DISENGAGED THE HEAD, WE MOBILIZED THE STEM, RETRACTED IT ANTERIORLY. WE REPLACED THE 10° LIPPED LINER. HOWEVER, WITH THIS IMPLANT, IT APPEARED THAT IT WAS NOT LOCKING SOLIDLY IN PLACE. I EXTRACTED THAT AND ATTEMPTED TO CEMENT THE LINER IN PLACE, BUT WE WERE UNABLE TO OBTAIN A VERY STABLE INTERFACE. AT THAT POINT, WE REMOVED THE LINER AND CEMENT AND REPLACED THE LINER WITH A NEW LINER THAT LOCKED CLEARLY VERY SOLIDLY IN PLACE (INTRA-OP EVENT REPORTED). THIS GAVE GOOD RANGE OF MOTION, GOOD ORIENTATION OF COMPONENTS. WE THEN THOROUGHLY IRRIGATED AND DEBRIDED ALL TITANIUM STAINED TISSUE AND RECONSTRUCTED THE POSTERIOR CAPSULE IN AN ANATOMIC FASHION, CLOSED THE WOUND IN THE USUAL FASHION. STERILE DRESSINGS APPLIED. THE PATIENT WAS AWAKENED AND REMOVED FROM THE OPERATING ROOM IN GOOD CONDITION.

  Patient problems: Arthritis; Joint Dislocation; Pain

  MAUDE report 11555838 ↗

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
• 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