Omnifit 2043C-2846Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540037169), received between Jul 22, 2019 and Jul 22, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN (POSSIBLE CAUSE OR CONTRIBUTOR FOR PAIN NOT REPORTED TO REP). THE HEAD AND LINER WERE EXCHANGED. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 8813324 ↗

Recalls under the same FDA submission

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

• 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