OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. 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. recalled 33,103 OPTETRAK Comprehensive Knee System devices, including OPTETRAK RBK PS Tibial Components, distributed worldwide across the United States and numerous other countries. The devices were packaged in vacuum bags that lacked an additional oxygen barrier layer, which is the reason for the recall.
The affected devices are identified by Item Number 264-21-09 with multiple serial numbers beginning with 0754387 through 0912211 and beyond. The recall was expanded on February 7, 2022. The source does not specify a remedy or recommended action 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: 33,103 devices Lot/code info: Item Number (Device Identifier; Serial number(s)): 264-21-09 (10885862068842; 0754387, 0754388, 0754390, 0754391, 0754392, 0754393, 0754394, 0754396, 0754397, 0754398, 0754399, 0754400, 0754401, 0754402, 0754403, 0754404, 0754405, 0754406, 0754407, 0754408, 0754409, 0754410, 0754411, 0754412, 0754413, 0754414, 0754415, 0754416, 0754417, 0754418, 0754419, 0754420, 0754421, 0754422, 0754423, 0754424, 0754425, 0754426, 0754427, 0782395, 0782396, 0782397, 0782398, 0782399, 0782400, 0782401, 0782402, 0782403, 0782404, 0782405, 0782406, 0782407, 0782408, 0782409, 0782410, 0782411, 0782412, 0782413, 0782414, 0782415, 0782416, 0782417, 0782418, 0782419, 0782420, 0782421, 0782422, 0782423, 0782424, 0782425, 0782426, 0782427, 0782428, 0782429, 0782430, 0782431, 0782432, 0782433, 0782434, 0782435, 0782436, 0782437, 0782438, 0782439, 0782440, 0782441, 0782442, 0862418, 0862420, 0862422, 0862424, 0862425, 0862426, 0862427, 0862428, 0862429, 0862430, 0862431, 0862432, 0862434, 0862435, 0862436, 0862437, 0862438, 0862439, 0862440, 0862441, 0862442, 0862443, 0862444, 0862445, 0862447, 0862448, 0862449, 0862450, 0862451, 0862452, 0862453, 0862454, 0862455, 0862456, 0862457, 0862458, 0862459, 0862460, 0862461, 0862462, 0862463, 0862464, 0862466, 0862468, 0862469, 0912159, 0912160, 0912168, 0912169, 0912171, 0912172, 0912175, 0912177, 0912178, 0912179, 0912180, 0912182, 0912187, 0912189, 0912192, 0912195, 0912197, 0912198, 0912201, 0912202, 0912203, 0912204, 0912205, 0912206, 0912207, 0912211,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.