Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Reason for recall: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Distribution: US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK Quantity: N/A Lot/code info: a) 02-023-02-0029, GTIN 10885862596376, Serial Numbers: A704613, A704614, A704618, A704633, A704634, A704649, A704651, A704632; b) 02-023-02-0032, GTIN 10885862596383, Serial Numbers: A703837, A703844, A703847, A703863, A704084, A704089, A704100, A704102, A704105, A704110, A704111, A704115, A704142, A704161, A704162, A704167, A704171, A704189, A704190, A704151, A704156, A704183; c) 02-023-02-0035, GTIN 10885862596390, Serial Numbers: A704258, A704282, A704299, A704300, A704306, A704314, A704320; d) 02-023-02-0038, GTIN 10885862596406, Serial Numbers: A704222, A704229, A704231, A704233, 704240, A704249; e) 02-024-35-1512, GTIN 10885862596741, Serial Numbers: A713224, A713230, A713233, A713234, A713237; f) 02-024-35-1515, GTIN 10885862596772, Serial Numbers: A697051; g) 02-024-35-1519, GTIN 10885862596796, Serial Numbers: A713345; h) 02-024-35-2010, GTIN 10885862596819, Serial Numbers: A701145, A701149, A701150, A701151, A701152, A701153, A701154, A701155, A701156, A701157, A701158, A701159, A701160, A701162, A701163, A701164, A701165, A701166; i) 02-024-35-2013, GTIN 10885862596840, Serial Numbers: A697420, A697421, A697423, A697424, A697425, A697427, A697428, A697430, A697431, A697434, A697435, A697437, A697438, A697439, A697440; j) 02-024-35-2015, GTIN 10885862596864, Serial Numbers: A701404, A701405, A701407, A701409, A701410, A701411, A701412, A701417, A701421, A701425, A701426, A701427, A701429, A701434; k) 02-024-35-2509, GTIN 10885862596895, Serial Numbers: A702432, A70
10885862596376, 10885862596383, 10885862596390, 10885862596406, 10885862596741, 10885862596772, 10885862596796, 10885862596819, 10885862596840, 10885862596864, 10885862596895, 10885862596901, 10885862596918, 10885862596925, 10885862596994, 10885862597007, 10885862597014, 10885862597021, 10885862597113, 10885862597137, 10885862597199, 10885862597205, 10885862597267, 10885862597311, 10885862597366, 10885862597373, 10885862597724, 10885862597793, 10885862597816, 10885862597854, 10885862597892, 10885862597946, 10885862597977, 10885862597991, 10885862598011, 10885862598035, 10885862598066, 10885862598158, 10885862598240, 10885862598264
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.