Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM 189704 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM Product Usage: Knee prosthesis

Reason: Potential presence of elevated endotoxin levels that exceed the specification limit

Code information: Lot Numbers: UDI Number 630770 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304448490(17)211228(10)630770 646170 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304448490(17)211227(10)646170 530980 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM (01)00880304556140(17)211228(10)530980 570570 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM (01)00880304448605(17)220106(10)570570 477430 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM (01)00880304493131(17)220115(10)477430 505490 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM (01)00880304556119(17)220115(10)505490

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.