FDAFDA · Food and drugs·Recall number Z-2154-2020
Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis
Published June 3, 2020 · Recall initiated: April 17, 2020
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
Potential presence of elevated endotoxin levels that exceed the specification limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.
- Lot
- Lot Numbers: UDI Number 508390 Vanguard Knee System, Series-A Standard Patella, 28 MM (01)00880304431638(17)211218(10)508390; 309810 Vanguard Knee System, Series-A Standard Patella, 31 MM (01)00880304431317(17)211228(10)309810
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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