Knee Products: 189260 Vanguard Knee System recall: Endotoxin
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…
Why was Knee Products: 189260 Vanguard Knee System recalled?
Potential presence of elevated endotoxin levels that exceed the specification limit
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- Biomet, Inc.
- Quantity
- 11 units
- Distribution
- 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.
- Recall date
- June 3, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)