Z-2154-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- April 17, 2020
- Termination Date
- June 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 91 units
Product Description
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
Reason for Recall
Potential presence of elevated endotoxin levels that exceed the specification limit
Distribution Pattern
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.
Code Information
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