Biomet Recalls Vanguard Knee System Tibial Bearings Due to Endotoxin Levels
Biomet, Inc. is recalling 46 units of Vanguard Knee System tibial bearings because they may contain elevated endotoxin levels that exceed specification limits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (endotoxin exposure) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Biomet, Inc. is recalling 46 units of Vanguard Knee System tibial bearings. The recall is due to the potential presence of elevated endotoxin levels that exceed the specification limit.
The affected products include Vanguard Knee System PS Tibial Bearings (12 MM X 63/67 MM and 10 MM X 63/67 MM) and Vanguard Knee System AS Tibial Bearings (18 MM X 67 MM and 12 MM X 75 MM). The distribution was worldwide, including the United States, Canada, and various countries in Asia, Europe, and the Americas.
Healthcare providers and patients should contact Biomet, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- 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 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers: UDI Number 443160 Knees Vanguard Knee System PS Tibial Bearing
- AS Tibial Bearing
- 12 MM X 75 MM (01)00880304436954(17)220119(10)678080
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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