Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component Recalled by Biomet, Inc. Due to Potential presence of elevated endotoxin levels that exceed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biomet, Inc. directly.
Affected Products
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 Component, 10 MM X 75 MM 155346 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155328 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM 155388 Knees AGC Knee System PS Molded Tibial component, 18 MM X 85 MM Product Usage: Knee prosthesis
Quantity: 54 units
Why Was This Recalled?
Potential presence of elevated endotoxin levels that exceed the specification limit
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Biomet, Inc.
Biomet, Inc. has 250 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report