Biomet Recalls AGC Knee System Tibial Components Due to Endotoxin Levels
Biomet, Inc. is recalling 54 units of AGC Knee System PS Molded Tibial Components 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 potential contamination hazard (endotoxin) that could cause harm, but the source text does not report any specific illnesses, injuries, or fatalities, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 54 units of AGC Knee System PS Molded Tibial Components. The recall was initiated because the products may contain elevated endotoxin levels that exceed the established specification limit.
The affected products are knee prostheses distributed worldwide, including in the United States, Canada, India, Japan, Mexico, the Netherlands, Singapore, and other international locations. The recall covers specific lot numbers and UDI numbers for various sizes of the tibial component.
Healthcare providers and patients should contact Biomet, Inc. for further information regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial Co
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 54
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 (2)
- Lot Numbers: UDI Number 570460 AGC Knee System PS Molded Tibial Component
- 18 MM X 85 MM (01)00880304246256(17)220118(10)494030
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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