Biomet Recalls Vanguard Knee Implants Due to Endotoxin Levels
Biomet, Inc. is recalling 91 Vanguard Knee System patella implants 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 is classified as FDA Class II and involves a high-risk pathogen (endotoxin) in a medical device 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 91 units of the Vanguard Knee System, Series-A Standard Patella (28 MM and 31 MM sizes) due to the potential presence of elevated endotoxin levels that exceed the specification limit. The affected products are knee prostheses intended for surgical use.
The recall covers units distributed worldwide, including the United States, Canada, and various locations in Asia, Europe, and South America. The specific lot numbers and UDI numbers for the affected 28 MM and 31 MM patellae are listed in the official recall documentation.
Healthcare providers and patients should contact Biomet, Inc. for further information regarding the recall and potential replacement or remediation of the affected implants.
The recalled product
- Product
- Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 91
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 (5)
- Lot Numbers: UDI Number 508390 Vanguard Knee System
- Series-A Standard Patella
- 28 MM (01)00880304431638(17)211218(10)508390
- 309810 Vanguard Knee System
- 31 MM (01)00880304431317(17)211228(10)309810
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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