Omnifit 2043C-2850Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540037176), received between Oct 16, 2018 and Oct 16, 2018 — 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 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.

• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED. PATIENT COMPLAINTS, PRE-OPERATIVE DIAGNOSES, INTRA-OPERATIVE FINDINGS WERE NOT REPORTED TO THE REP. A HEAD AND LINER WERE EXCHANGED.

  Patient problems: Injury

  MAUDE report 7971082 ↗

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