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OMNI K2 HipRecalls & reported problems across all models

Omni Life Science, Inc. · 5 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
7
Recalls
1

We found 5 models of OMNI K2 Hip by Omni Life Science, Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2017 and Feb 7, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

OMNI K2 Hip recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Oct 1, 2021Terminated

    The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.

    Z-0237-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported OMNI K2 Hip problems

Device problems

  • Insufficient Device Problem Information3
  • Appropriate Device Problem Term/Code Not Available1
  • Device Dislodged or Dislocated1
  • Device Operates Differently Than Expected1
  • Nonstandard Device1
  • Patient-Device Incompatibility1

Patient problems

  • Osteolysis3
  • Insufficient Information2
  • Autoimmune Reaction1
  • Joint Dislocation1
  • Pain1
  • Unequal Limb Length1

OMNI K2 Hip models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent OMNI K2 Hip adverse event reports

The 8 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Omni Life Science, Inc. products

All Omni Life Science, Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page