Reported Jun 3, 2020 · Terminated
Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS…
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 Products189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189426 Vanguard Knee System, PS Mono Lock Tibial Bearing, 16 MM X 63 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM
- Lot codes and dates
- Lot NumbersUDI Number 530900 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)211223(10)530900 548950 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM (01)00880304451360(17)211222(10)548950 602870 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM (01)00880304451360(17)211228(10)602870 530930 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211223(10)530930 588890 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211223(10)588890 602930 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211228(10)602930 697510 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211227(10)697510 700830 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211228(10)700830 530940 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)211223(10)530940 758560 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)211228(10)758560 758580 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)211223(10)758580 884710 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)211229(10)884710 570620 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220106(10)570620 884680 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220107(10)884680 828010 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220106(10)828010 855380 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220111(10)855380 855390 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220111(10)855390 772740 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)220112(10)772740 796110 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)220115(10)796110 796120 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)220112(10)796120 796150 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220112(10)796150 828040 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220115(10)828040 830730 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220115(10)830730 727060 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)220121(10)727060 505430 Vanguard Knee System, PS Mono Lock Tibial Bearing, 16 MM X 63 MM (01)00880304454859(17)220125(10)505430 581950 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220121(10)581950 608380 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220118(10)608380 644080 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220118(10)644080 708620 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220121(10)708620 758570 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220118(10)758570
- Amount recalled
- 107 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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