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Exactech, Inc. recalls OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX).
Recalled October 13, 2021 · FDA recall Z-0026-2022 · Exactech
Hazard
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. · FDA Class II
Units
8,985 devices
Sold at
Worldwide distribution - US Nationwide distribution and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, ECUADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GHANA, GREAT BRITAIN, GREECE, GUATEMALA, INDIA, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, ROMANIA, SINGAPORE, SPAIN, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TUNISIA, TURKEY, VENEZUELA .
Description
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Product
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →