Omnifit 2041C-3258Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540035813), received between Aug 16, 2018 and Aug 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2018Device-Device Incompatibility; Device-Device Incompatibility

  WHILE PERFORMING A REVISION OF THE PATIENT'S RIGHT HIP, THE POLY WOULD NOT FULLY LOCK INTO THE SHELL. THE DEVICE APPEARED FLUSH (NOT SITTING PROUD), BUT STILL ALLOWED MICRO-MOTION WITHIN THE SHELL. A SECOND POLY WAS OPENED AND USED WITH NO ISSUES. A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES WAS REPORTED. REP REPORTED THAT HOSPITAL WILL RELEASE NO FURTHER INFORMATION DUE TO ITS INTERPRETATION OF HIPAA. UPDATE 25-JUL-2018: REP PROVIDED A USAGE SHEET WHICH ALSO SHOWED A SERIES II LINER AS WASTED. REP REPORTED THAT THE SURGEON HAD TRIED THAT LINER FIRST, BUT IT WASN'T STABLE. SURGEON THEN TRIED THE SECOND LINER ORIGINALLY REPORTED. A SCREW, ALSO WASTED, WAS ONLY USED TO REMOVE THE 2 REPORTED LINERS. UPDATE 26-JUL-2018: REP ADDRESSED THE REPORT OF THE SERIES II LINER BEING UNSTABLE: "THE INSTABILITY WAS RELATED TO THE ROM AND LIKELY ASSOCIATED TO THE PATIENTS SOFT TISSUE ANATOMY FROM REVISION SURGERY. IT WAS NOT RELATED TO THE IMPLANT". THE SERIES II IMPLANT WAS DISPOSED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7788277 ↗

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