Knee Products: 189420 Vanguard Knee System recall: Endotoxin
Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM…
Why was Knee Products: 189420 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 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
- Product
- Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM…
- Recalling firm
- Biomet, Inc.
- Quantity
- 107 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)