FDAFDA · Food and drugs·Recall number Z-0833-2019
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
Published February 20, 2019 · Recall initiated: December 10, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product mix up
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Signature Orthopedics Pty Limited
- Distributor
- US Nationwide Distribution in the states of FL, NY, and TN
- Lot
- UDI # 09348215020309 Device Model # 121-07-4004 Lot # 77A3F
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Australia
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