FDA-Device2020-06-03Class II
Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
Biomet, Inc.
Hazard
Potential presence of elevated endotoxin levels that exceed the specification limit
Sold states
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.
Affected count
12 units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2147-2020Don't want to check this manually?
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