Biomet, Inc.: 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 Vanguard Knee System, AS Tibial Bear

Is my product affected?

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 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM

• UPC 00880304271869
• UPC 00880304271852
• UPC 00880304436947
• UPC 00880304436954

Check against the official notice below — it lists the full affected range.

What happened

Biomet, Inc. is recalling specific lots of Vanguard Knee System tibial bearing components due to the potential presence of elevated endotoxin levels that exceed specification limits. The affected products include four lot numbers of PS and AS tibial bearings in various sizes, with a total of 46 units distributed worldwide to the United States and multiple international locations including Canada, India, Japan, Mexico, Thailand, Singapore, Taiwan, and other countries.

The source document does not specify a remedy for consumers who may have received these products.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential presence of elevated endotoxin levels that exceed the specification limit

Details from the source

Reason for recall: Potential presence of elevated endotoxin levels that exceed the specification limit 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. Quantity: 46 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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