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.
Check against the official notice below — it lists the full affected range.
Exactech, Inc. is recalling 2,774 OPTETRAK Comprehensive Knee System devices, including OPTETRAK All-polyethylene UNI Tibial Components, across multiple product lines. The inserts in these devices were packaged in vacuum bags that lacked an additional oxygen barrier layer, which is the reason for the recall. The affected devices were distributed worldwide, including throughout the United States and in countries such as Canada, Australia, Japan, Germany, France, Brazil, Mexico, China, India, and many others.
The specific recalled devices are identified by item numbers 252-12-01, 252-12-02, 252-13-01, 252-13-02, 252-22-01, 252-22-02, 252-23-01, and 252-23-02, along with their corresponding serial numbers. The recall record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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: 2,774 devices Lot/code info: Item Number (Device Identifier; Serial number(s)): 252-12-01 (10885862065759; 0757895, 0757903, 0757904, 0757912, 0779752, 0779753, 0779755, 0779756, 0779757, 0779761, 0779762, 0779763, 0779764, 0779765, 0779766, 0779768, 0779769, 0779771, 1411813, 1411814, 1411816, 1454118, 1454120, 1454121, 1454122, 1637857, 1637859, 1637862, 1637863, 1705486, 1705487, 1705488, 1705489, 1705491, 1705492, 1705499, 1705500, 1777268, 1777272, 1838362, 1838363, 1838366, 1845014, 1845017, 1845018, 1876225, 1876228, 1876229, 1966561, 1966562, 1966563, 1966565, 2058877, 2058880, 2058883, 2236096, 2236097, 2236100, 2388362, 2388363, 2388364, 2388365, 2782155, 2787073, 2787075, 2787076, 3664728, 3664729, 4149824, 4149840); 252-12-02 (10885862065766; 1064337, 1064339, 1064340, 1064341, 1064342, 1064343, 1064344, 1064345, 1064347, 1064348, 1064349, 1064350, 1064351, 1064352, 1064353, 1064354, 1064355, 1064356, 1064357, 1064358, 1257124, 1257125, 1257126, 1257127, 1257128, 1257130, 1257131, 1257132, 1257135, 1257136, 1257138, 1257141, 1257145, 1257146, 1257147, 1257148, 1257149, 1257150, 1257151, 1257152, 1257153, 1257154, 1257156, 1257157, 1257158, 1257159, 1257160, 1257163, 1257164, 1257165, 1257166, 1257167, 1257168, 1257169, 1257170, 1257171, 1257173, 1257175, 1257176, 1257177, 1257178, 1257179, 1257181, 1856545, 1856546, 1856547, 1856549, 1856550, 1856551, 1856552, 1856554, 1896395, 1896396, 1896397, 1896398, 1896399, 1896400, 1896401, 1896404, 2116639, 2116640, 2116641, 2116642, 2116644, 2288472,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.