Omnifit 2001-2848Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327038095), received between Dec 8, 2022 and Dec 8, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

1 other recall cover devices cleared under the same FDA submission (K850352, K900438); 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. How this data works · Data updated Oct 13, 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.

• InjuryDec 8, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SUSPECTED ASEPTIC LOOSENING OF THE SHELL. INTRA-OPERATIVELY, SHELL LOOSENING WAS CONFIRMED AND ECENTRIC POLY WEAR WAS OBSERVED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 15940449 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K850352, K900438. One submission often covers many models, so check the product and lot details in each record.

• Z-3196-2026 · Jul 30, 2026 · Open, Classified
  OMNIFIT SERIES I ACET. INSERT 10 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)