Reported Jun 3, 2020 · Terminated
Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System,…
Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- Knee Products189260 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 UsageKnee prosthesis
- Lot codes and dates
- Lot NumbersUDI 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
- Amount recalled
- 11 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential presence of elevated endotoxin levels that exceed the specification limit
This product could cause temporary or reversible health problems — stop using it.
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