Biomet Vanguard Knee System Recalled for Elevated Endotoxin Levels
Biomet, Inc. is recalling 11 units of Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding 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 high-risk medical device (knee prosthesis) with a potential contamination hazard (endotoxin) 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 11 units of Vanguard Knee System tibial bearings. The recall involves specific CR and CR-L Mono Lock Tibial Bearings in various sizes, including 10 MM X 71 MM, 10 MM X 83 MM, 10 MM X 79 MM, and 14 MM X 79 MM.
The reason for the recall is the potential presence of elevated endotoxin levels that exceed the specification limit. Endotoxins are substances that can cause adverse health effects if present in medical devices at high concentrations.
The affected products were distributed worldwide, including in the United States, Canada, India, Japan, Mexico, the Netherlands, Singapore, Taiwan, Thailand, and other locations. Healthcare providers and patients who have received these specific knee prostheses should contact Biomet, Inc. for further instructions.
The recalled product
- Product
- Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono Lock
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 11
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 (4)
- Lot Numbers: UDI Number 630770 Vanguard Knee System
- CR-L Mono Lock Tibial Bearing
- CR Mono Lock Tibial Bearing
- 14 MM X 79 MM (01)00880304556119(17)220115(10)505490
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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