Exactech, Inc.: OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Li

Is my product affected?

OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Ti

• UPC 10885862001641
• UPC 10885862001658
• UPC 10885862001665
• UPC 10885862001672
• UPC 10885862001689
• UPC 10885862001696
• UPC 10885862001702
• UPC 10885862001719
• UPC 10885862247292
• UPC 10885862247308
• UPC 10885862180759

Check against the official notice below — it lists the full affected range.

What happened

Exactech, Inc. has recalled 109,787 OPTETRAK Logic polyethylene tibial inserts used in knee replacement procedures. The inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. The affected products include OPTETRAK Logic PS Tibial Inserts and OPTETRAK Logic PSC Tibial Inserts across multiple lot and serial numbers. These devices were distributed worldwide, including throughout the United States and in countries including Canada, Australia, Japan, Germany, France, Brazil, Mexico, and many others.

The source document does not specify what actions an affected consumer should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Details from the source

Reason for recall: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Distribution: 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, SING Quantity: 109,787 devices Lot/code info: a. Item Number (Device Identifier; Serial number(s)): 02-012-35-0009 (10885862001641; 1678465, 1678471, 1678474, 1678481, 1957753, 2006036, 2006037, 2013812, 2043308, 2092688, 2554898, 2573058, 4705904); 02-012-35-0011 (10885862001658; 1678302, 1678309, 1678312, 1963089, 2019801, 2104502, 2104504, 2363227, 2666629, 3809531, 3809537, 4760880); 02-012-35-0013 (10885862001665; 1678446, 1678450, 2092581, 2092584, 2523130); 02-012-35-0015 (10885862001672; 1677680); 02-012-35-1009 (10885862001689; 1393427, 1393428, 1393429, 1393430, 1393431, 1393432, 1393433, 1393435, 1393436, 1393437, 1393438, 1393439, 1393440, 1393441, 1398561, 1398562, 1398563, 1398564, 1398568, 1398569, 1398573, 1398575, 1398578, 1398579, 1398580, 1398581, 1398582, 1398583, 1398584, 1398586, 1398587, 1398588, 1398589, 1398590, 1469287, 1469288, 1469289, 1469290, 1469291, 1469292, 1469293, 1469294, 1469296, 1472031, 1472032, 1472033, 1472034, 1472035, 1472038, 1472040, 1472042, 1472043, 1472044, 1472046, 1472047, 1486523, 1486525, 1486526, 1486527, 1486528, 1486529, 1486530, 1486531, 1486533, 1486534, 1486536, 1486537, 1486538, 1486539, 1486541, 1486542, 1486546, 1486548, 1486549, 1486550, 1486551, 1486552, 1491788, 1491789, 1491790, 1634088, 1634089, 1634090, 1634091, 1634092, 1634095, 1634097, 1736119, 1736121, 1736122, 1736123, 1736124, 1736125, 1736126, 1736127, 1736129, 1736130, 1736132, 1736133, 1736134, 1736135, 1736136, 1736137, 1736138, 1736140, 1736142, 1736143, 1736144, 1736145, 1736146, 1764587, 1764

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12021-08-30
• OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.2021-08-30
• OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX). NOTE: Information re2021-08-30
• TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: In2021-08-30
• Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.2021-08-30

All FDA (Device enforcement) recalls