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Biomet, Inc. recalls Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS
Recalled June 3, 2020 · FDA recall Z-2149-2020 · Biomet
Hazard
Potential presence of elevated endotoxin levels that exceed the specification limit · FDA Class II
Units
54 units
Sold at
Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.
Description
Potential presence of elevated endotoxin levels that exceed the specification limit
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 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
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →