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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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