Reported Feb 20, 2019 · Terminated

Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component

Signature Orthopedics Pty Limited

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: Signature Orthopedics Pty Limited · Lane Cove W · Lane Cove West, N/A · N/A

Is this the product you have?

  • Genius Knee Cemented
  • CR Femoral Component Product UsageKnee replacement component
Lot codes and dates
  • UDI # 09348215020330 Device Model # 121-07-3000 Lot # 788F7-1
Amount recalled
3

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Product mix up

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 Dec 14, 2020 · Data as of Sep 19, 5:33 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.