Reported Oct 30, 2019 · Terminated

OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary…

OMNIlife science Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: OMNIlife science Inc. · 480 Paramount Dr · Raynham, MA · 02767-1085

Is this the product you have?

  • OMNI Hip System Model, Catalogue
  • or Order Number(s)HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement
Lot codes and dates
  • Lot # 33035
Amount recalled
3 units

Where it was sold

Why it was recalled

Stems missing porous coating on the device.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 27, 2020 · Data as of Sep 19, 6:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.