Exactech, Inc.: 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 0

Is my product affected?

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.

• UPC 10885862002358
• UPC 10885862002365
• UPC 10885862002372
• UPC 10885862002389
• UPC 10885862178794
• UPC 10885862178800
• UPC 10885862178817
• UPC 10885862002396
• UPC 10885862002402
• UPC 10885862002419
• UPC 10885862002426
• UPC 10885862178831
• UPC 10885862178848
• UPC 10885862178855
• UPC 10885862178862
• UPC 10885862002433

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

What happened

Exactech, Inc. is recalling 8,985 OPTETRAK Comprehensive Knee System devices, specifically the OPTETRAK Logic RBK PS Tibial Components with item number 02-012-38-1009. The devices were packaged in vacuum bags that lacked an additional oxygen barrier layer, which is the reason for the recall. These devices were distributed worldwide, including throughout the United States and in numerous countries across Europe, Asia, the Americas, Africa, and Oceania.

The recall involves multiple serial numbers associated with the affected device. The record does not specify a remedy for affected consumers.

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: 8,985 devices Lot/code info: Item Number (Device Identifier; Serial number(s)): 02-012-38-1009 (10885862002358; 2109242, 2109243, 2109244, 2109245, 2109246, 2109247, 2109248, 2109249, 2109250, 2109251, 2109252, 2109253, 2109254, 2109255, 2109256, 2109257, 2109258, 2109261, 2109262, 2109263, 2109265, 2109267, 2109268, 2109269, 2109270, 2109271, 2109272, 2109273, 2109274, 2328032, 2328033, 2328034, 2356324, 2356325, 2356326, 2356327, 2356328, 2356329, 2356330, 2356331, 2356332, 2356334, 2356335, 2356336, 2573198, 2573199, 2573200, 2573201, 2573202, 2573203, 2573204, 2974115, 2974116, 2974117, 2974118, 2974119, 2991806, 2991807, 2991808, 2991809, 2991810, 3628492, 3628493, 3628494, 3628496, 3628499, 3628500, 3628501, 3628502, 3628503, 3628504, 3628506, 3628508, 3628509, 3628510, 3628511, 3826220, 3826221, 3826222, 3870061, 3870062, 3870063, 3870064, 3870065, 3870066, 3870067, 3870068, 3870069, 3870070, 3873437, 3873438, 3873439, 3873440, 3873441, 3873442, 3873444, 3873445, 3873446, 3873447, 3873448, 3873449, 3873451, 3873452, 3873453, 4036097, 4036098, 4036099, 4036100, 4036101, 4036102, 4036103, 4036104, 4036105, 4036108, 4036110, 4036111, 4095990, 4095991, 4095992, 4095993, 4095994, 4095995, 4095997, 4095998, 4095999, 4096000, 4096002, 4096003, 4096004, 4291075, 4291076, 4291077, 4291078, 4291079, 4291081, 4291082, 4291083, 4291085, 4291086, 4291087, 4291088, 4291090, 4291091, 4291092, 4291094, 4291095, 4291096, 4291097, 4291098, 4291099, 4291100, 4291101, 4291102, 4291103, 4706381, 4706382, 4706383, 4706

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 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 + Ti2021-08-30
• 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

All FDA (Device enforcement) recalls