Knee Products: 183622 Vanguard Knee System PS Tibial recall: Endotoxin
Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048…
Why was Knee Products: 183622 Vanguard Knee System PS Tibial 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 443160 Knees Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM (01)00880304271869(17)211230(10)443160 458440 Knees Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM (01)00880304271852(17)220105(10)458440 376090 Knees Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM (01)00880304436947(17)220113(10)376090 678080 Knees Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM (01)00880304436954(17)220119(10)678080
- Product
- Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048…
- Recalling firm
- Biomet, Inc.
- Quantity
- 46 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)