Biomet Vanguard Knee System Recalled for Elevated Endotoxin Levels
Biomet is recalling 93 Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding specifications. The recall covers units distributed worldwide.
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 the hazard involves a high-risk pathogen (endotoxin) without reported illness, fitting the 'High' severity criteria.
Plain-English summary
Biomet, Inc. is recalling 93 units of the Vanguard Knee System, specifically PS+ and PS Tibial Bearings, due to the potential presence of elevated endotoxin levels that exceed the specification limit. The affected products include various sizes and configurations of the knee prosthesis components.
The recall involves specific lot numbers and UDI numbers for the PS+ Tibial Bearing (12 MM and 14 MM) and the PS Tibial Bearing, E1 Infused (18 MM X 59 MM). These medical devices were distributed worldwide, including in the United States, Canada, India, Japan, Mexico, the Netherlands, Singapore, and other international locations.
Healthcare providers and patients should check their inventory and patient records for the specific lot numbers and UDI numbers listed in the recall notice. If the affected products are in use, providers should contact Biomet, Inc. for further instructions on replacement or removal.
The recalled product
- Product
- Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee Sys
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 93
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 (7)
- Lot Numbers: UDI Number 294130 Knees Vanguard Knee System
- PS+ Tibial Bearing
- 12 MM
- PS Tibial Bearing
- E1 Infused
- 14 MM
- 18 MM X 59 MM (01)00880304476714(17)220103(10)509990R
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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