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, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

What Should You Do?

1. Check if you have this product:
   a. Item Number (Device Identifier; Serial number(s)): 200-11-11 (10885862039934; 1010599); 200-12-09 (10885862039965; 0850770, 0850771, 0850773, 0850776, 0850778, 1052587, 1052589, 1070149, 1070150, 1070151, 1070152, 1267585, 1267586, 1267588, 1318739, 1318740, 1318742, 1375833, 1375836, 1375837, 1375839, 1375844); 200-12-11 (10885862039972; 0825651, 0825653, 0825654, 0825657, 0825659, 1052802, 1052803, 1052804, 1309224); 200-12-13 (10885862039989; 0763041, 0763043, 0820424, 0820431, 1053775); 200-13-09 (10885862039996; 0765380, 0765381, 0765382, 0765383, 0789723, 0789724, 0789726, 0789727, 0789728, 0789729, 0789730, 0789731, 0789732, 0897683, 0998654, 0998655, 0998656, 0998657, 0998658, 0998659, 0998660, 0998661, 0998662, 0998663, 0998664, 0998665, 0998666, 1073908, 1073909, 1073910, 1073911, 1084202, 1084203, 1084204, 1084205, 1261436, 1261437, 1261438, 1261439, 1261440, 1316122, 1316123, 1316124, 1316125, 1316126, 1319147, 1319148, 1319149, 1319150, 1319151, 1407772, 1407774, 1407775, 1407776, 1407777, 1407778, 1407779, 1407780, 1407781, 1516714, 1516715, 1516716, 1516717, 1516718, 1976718, 1976719, 1976720, 1976721, 1976722, 2061574, 2097473, 2097474, 2097475, 2097476, 2097477, 2097478, 2097479, 2145890, 2145891, 2145892, 2145894, 2145895, 2145896, 2559776); 200-13-11 (10885862040008; 0769998, 0770002, 0770003, 0770004, 0818558, 0818559, 0818560, 0818562, 0818563, 0818564, 0818565, 1027748, 1027750, 1027752, 1027754, 1084902, 1291129, 1291130, 1291131, 1319746, 1319747, 1319748, 1319752, 1319753, 1319754, 1319756); 200-13-13 (10885862040015; 0767606, 0767607, 0767608, 0767609, 0953412, 1063120, 1307627); 200-14-09 (10885862040039; 0607230, 0607231, 0607232, 0607233, 0607234, 0607235, 0607236, 0607237, 0607238, 1033676, 1033677, 1033678, 1033679, 1040785, 1040786, 1040787, 1040788, 1065019, 1065020, 1065021, 1065022, 1065023, 1065024, 1065025, 1153592, 1153593, 1153594, 1153595, 1153596, 1153597, 1153598, 1153599, 1153600, 1215318, 1215319, 1215320, 1215322, 1281462, 1281463, 1281464, 1281465, 1321078, 1321079, 1321080, 1321081, 1321082, 1389683, 1389684, 1389685, 1400987, 1400988, 1400989, 1400990, 2012144, 2012145, 2048510, 2048511, 2207641, 2207642, 2207643, 2345327, 2345328, 2414649, 2414652, 2454327, 2454328, 2454329, 2565530, 2565533, 2565534); 200-14-11 (10885862040046; 0942385, 0942386, 0942393, 1050502, 1310607); 200-14-13 (10885862040053; 0942535, 1048228, 1048232, 1153792); 200-15-09 (10885862040077; 0822759, 0822761, 0822762, 0822764, 0822765, 0822766, 0822767, 1048609, 1048611, 1048612, 1048614, 1048615, 1048616, 1048617, 1136150, 1136151, 1136152, 1136154, 1214791, 1214792, 1214793, 1214794, 1214795, 1214796, 1283152, 1283153, 1283154, 1283155, 1439852, 1439853, 1439855, 1439856, 2146108, 2146113); 200-15-11 (10885862040084; 1065636, 1065638); 200-15-13 (10885862040091; 0954497, 0954501); 200-16-11 (10885862040121; 1040633, 1040634, 1040635, 1040636, 1073405, 1073407, 1084258); 200-16-13 (10885862040138; 0956887); b. Item Number (Device Identifier; Serial number(s)): 204-11-09 (10885862047823; 0961663, 0961665, 0961666, 0961667, 0961668, 0961669, 0961671, 0961672, 1045876, 1045877, 1045879, 1070620, 1070622, 1070623, 1106799, 1106800, 1106801, 1106802, 1106803, 1106805, 1106807, 1193435, 1193437, 1193438, 1193439, 1232147, 1232151, 1255910, 1255911, 1255912, 1255913, 1255914, 1270806, 1270807, 1270808, 1270809, 1308220, 1308221, 1308222, 1308223, 1308224, 1308225, 1377016, 1377017, 1377018, 1377019, 1377020, 1377021, 1377022, 1377023, 1377024, 1377025, 1545261, 1545262, 1545263, 1545264, 1545265, 1565700, 1565701, 1565702, 1565703, 1565704, 1582779, 1582780, 1582781, 1582782, 1582783, 1582784, 1582785, 1582786, 1582787, 1582788, 1582789, 1582790, 1582791, 1582792, 1582793, 1582794, 1582795, 1582796, 1582797, 1582798, 1659777, 1659778, 1659779, 1659780, 1659781, 1659782, 1659783, 1659784, 1659785, 1659786, 1659787, 1659788, 1659789, 1659790, 1659791, 1659792, 1659793, 1659794, 1659795, 1659796, 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4175250, 4175251, 4175252, 4175253, 4175254, 4175255, 4175256, 4205182, 4205183, 4205184, 4205185, 4205186, 4331818, 4331819, 4331820, 4331821, 4331822, 4331823, 4331824, 4331825, 4331826, 4367437, 4367438, 4367439, 4367440, 4367441, 4367442, 4367443, 4367444, 4399568, 4399569, 4399570, 4399571, 4399572, 4399573, 4399574, 4399575, 4399576, 4399577, 4933848, 4933849, 4933851, 4933852, 4933853, 4933854, 4933855, 4933856, 4933857, 4933858, 4933859, 4933860, 4933861, 4933862, 4933863, 4933864, 4933865, 4933866, 4933867, 4933868, 4933869, 4933870, 4933871, 4933872, 4933873, 4933874, 4933875, 4933876, 4933877, 4933878, 4933879, 4933880, 4933881, 4933882, 4933883, 4933884, 4933885, 4933887, 4945297, 4945298, 4945299, 4945300, 4945301, 4945302, 4945303, 4945304, 4945305, 4945306, 4945307, 4945308, 4945309, 4945310, 4945311, 4945312, 4945313, 4945314, 4945315, 4945316, 4945317, 4945318, 4945319, 4945320, 4945321, 4945322, 4945323, 4945324, 4945325, 4945326, 4945327, 4945328, 4945329, 4945330, 4945331, 4945332, 4945333, 4945334, 5086208, 5086209, 5086210, 5086211, 5086212, 5086213, 5086214, 5086215, 5086216, 5086217, 5086218, 5086219, 5086220, 5172053, 5172054, 5172055, 5172056, 5172057, 5172058, 5172059, 5180020, 5180021, 5180022, 5180023, 5180024, 5180025, 5180026, 5188774, 5188775, 5188776, 5209513); 204-11-11 (10885862047830; 0971418, 0971419, 0971420, 0971421, 0971422, 0971423, 1015616, 1015617, 1015618, 1015619, 1047575, 1047577, 1047578, 1066792, 1066793, 1066794, 1087082, 1087083, 1087084, 1087085, 1087086, 1168686, 1168687, 1187090, 1187092, 1187093, 1187094, 1187096, 1187098, 1187099, 1255900, 1255901, 1255902, 1255903, 1255904, 1255905, 1255906, 1255907, 1255908, 1255909, 1270537, 1270540, 1294283, 1294284, 1294285, 1294287, 1294288, 1294289, 1294290, 1307222, 1307223, 1307224, 1307225, 1392229, 1392230, 1392231, 1392232, 1392233, 1576699, 1576700, 1576701, 1576702, 1576703, 1576704, 1576705, 1585601, 1585602, 1585603, 1585604, 1585605, 1585606, 1585607, 1585608, 1585609, 1585610, 1585611, 1585612, 1585613, 1585614, 1585615, 1585616, 1585617, 1585618, 1585619, 1585620, 1585621, 1585622, 1585623, 1585624, 1585625, 1585626, 1585627, 1585628, 1585629, 1585630, 1585631, 1585632, 1745600, 1745601, 1745602, 1745603, 1745604, 1774126, 1774127, 1774128, 1774129, 1774130, 1774131, 1774132, 1774133, 1774134, 1774135, 1774136, 1774137, 1786761, 1786762, 1786763, 1786764, 1786765, 1786766, 1786767, 1786768, 1810253, 1810254, 1810255, 1810256, 1810257, 1810258, 1810259, 1810260, 1810261, 1821731, 1821732, 1821733, 1821734, 1821735, 1821736, 1821737, 1821738, 1821739, 1821740, 1821741, 1865512, 1865513, 1865515, 1897369, 1897370, 1897371, 1897373, 1897374, 1897375, 1897376, 1897377, 2265900, 2265901, 2265902, 2265903, 2265904, 2306144, 2306145, 2306146, 2306147, 2306148, 2306149, 2306150, 2306151, 2306153, 2306154, 2306155, 2306156, 2306157, 2306158, 2306159, 2306160, 2306161, 2306163, 2306164, 2306165, 2306166, 2306167, 2306168, 2306169, 2306170, 2306171, 2306172, 2430406, 2430407, 2430408, 2430409, 2430410, 2430411, 2430412, 2430413, 2430414, 2430415, 2582070, 2582071, 2582072, 2582073, 2582074, 2582075, 2582076, 2628063, 2628064, 2628065, 2628066, 2628067, 2628068, 2628069, 2628070, 2628071, 2628072, 2628073, 2628074, 2628075, 3545581, 3545582, 3545583, 3616391, 3616392, 3616393, 3616394, 3616395, 3636926, 3636927, 3644006, 3654371, 3654372, 3654373, 3654374, 3654375, 3654376, 3729486, 3756690, 3775777, 3775778, 3776705, 3776706, 3776707, 3776708, 3776709, 3811782, 3811783, 3811784, 3811785, 3811786, 3811787, 3811788, 3811789, 3811790, 3811791, 4053394, 4053395, 4053396, 4053397, 4053398, 4053399, 4053400, 4053401, 4053402, 4053403, 4053404, 4053405, 4053406, 4053407, 4053408, 4205187, 4205188, 4205189, 4205190, 4205191, 4226766, 4226767, 4226768, 4226769, 4226770, 4226772, 4226773, 4226774, 4226775, 4349216, 4349217, 4349218, 4349219, 4349220, 4349221, 4349222, 4349223, 4349224, 4384105, 4384106, 4384107, 4384108, 4384109, 4384110, 4384111, 4384112, 4384113, 4384114, 4816187, 4816188, 4816189, 4846027, 4846028, 4846029, 4846030, 4846031, 4846032, 4846033, 4846034, 4846035, 4846036, 4846037, 4846038, 4846039, 4846040, 4846041, 4846042, 4846043, 4846044, 4846045, 4846046, 4846047, 4846048, 4846049, 4846050, 4846051, 4846052, 4934866, 4934867, 4934868, 4934869, 4934870, 4934871, 4934872, 4934873, 4934874, 4934875, 4934876, 4934877, 4934878, 4934879, 4934880, 4934881, 4934882, 4934883, 4934884, 4934885, 4934886, 4934887, 4934888, 4934889, 4934890, 4965321, 4965322, 4965323, 4965324, 4965325, 4965326, 4965327, 4965328, 4965329, 4965330, 4965331, 4965332, 4965333, 4965334, 4965335, 4965336, 4965337, 4965338, 4965339, 4965340, 4965341, 4965342, 4965343, 4965344, 4965345, 5009433, 5009434, 5009435, 5009436, 5009437, 5009438, 5009439, 5009440, 5009441, 5009442, 5009443, 5009444, 5009446, 5009447, 5009448, 5009449, 5009450, 5009451, 5009452, 5009453, 5009454, 5009455, 5009457, 5179063); 204-11-13 (10885862047847; 0961673, 0961674, 0961675, 0961677, 0961678, 0961680, 1021516, 1021517, 1021518, 1021519, 1031608, 1031609, 1031610, 1053779, 1053780, 1053781, 1098258, 1098259, 1201250, 1201251, 1201252, 1201254, 1201255, 1259004, 1259005, 1259006, 1259007, 1259008, 1307220, 1307221, 1328794, 1328795, 1328796, 1328797, 1328798, 1328799, 1328800, 1328801, 1328802, 1328803, 1328804, 1328805, 1328806, 1597232, 1597233, 1597234, 1597235, 1597236, 1597237, 1597239, 1597240, 1597241, 1627673, 1627674, 1627675, 1627676, 1627677, 1627678, 1627679, 1647931, 1647932, 1647933, 1647934, 1647935, 1659319, 1659320, 1659321, 1659323, 1766122, 1766123, 1766124, 1766125, 1766126, 1766127, 1766128, 1766129, 1766130, 1766131, 1766132, 1766133, 1766134, 1767874, 1767875, 1767876, 1767877, 1767878, 1767879, 1767880, 1767881, 1767882, 1767883, 1767884, 1767885, 1767886, 1852794, 1852795, 1852796, 1852797, 1852798, 1852799, 1852800, 1852801, 1852802, 1852803, 1903394, 1903395, 1903396, 1903398, 1903399, 1903401, 1903402, 1903403, 1903404, 1903405, 1903406, 1903410, 1903411, 1903412, 2259858, 2259859, 2259860, 2259861, 2259862, 2259863, 2259864, 2259865, 2259866, 2259867, 2398501, 2398502, 2398503, 2398504, 2398505, 2398506, 2398507, 2398508, 2398509, 2430396, 2430397, 2430398, 2430399, 2430400, 2430401, 2430402, 2430403, 2430404, 2430405, 2640147, 2640148, 2640149, 2640150, 2640151, 2640152, 2640153, 2640154, 2640155, 2640156, 2725662, 2725664, 2725665, 2725666, 2725667, 2725668, 2725669, 2725671, 2725672, 2725674, 2725676, 2725677, 2725678, 2725679, 2725680, 2725681, 2815981, 2926604, 2926605, 2926606, 2926607, 2926608, 2926609, 2926610, 2926611, 2926612, 3647961, 3647963, 3647964, 3647966, 4081311, 4081312, 4081313, 4081314, 4081315, 4124295, 4124298, 4124299, 4124300, 4124301, 4124302, 4124303, 4124304, 4124305, 4124307, 4124308, 4124309, 4124310, 4124311, 4124312, 4124314, 4124315, 4124316, 4124317, 4124318, 4384097, 4384098, 4384099, 4384100, 4384101, 4384102, 4384103, 4384104, 5084582, 5084583, 5084584, 5084585, 5084586); 204-12-09 (10885862047885; 0881042, 0881043, 0895287, 0895288, 0895289, 0895290, 0895291, 0895292, 0895293, 0895294, 0895295, 0957833, 0957834, 0957835, 0957836, 0957837, 1019604, 1019605, 1021520, 1021521, 1021522, 1021523, 1021524, 1045910, 1045911, 1045912, 1045913, 1045914, 1079090, 1079091, 1079092, 1079093, 1097012, 1097013, 1097014, 1097015, 1122249, 1122250, 1122251, 1122252, 1122253, 1150183, 1150185, 1173036, 1173037, 1173038, 1173039, 1173040, 1208280, 1215635, 1215636, 1215639, 1230263, 1230264, 1230265, 1230266, 1230267, 1230268, 1230269, 1230270, 1237521, 1237522, 1237523, 1237524, 1237525, 1265772, 1265773, 1265774, 1294243, 1294244, 1294245, 1300708, 1300709, 1300710, 1300711, 1300712, 1300713, 1300714, 1300715, 1324324, 1324325, 1324326, 1324327, 1324328, 1324330, 1324332, 1324333, 1326334, 1326335, 1326336, 1326337, 1326338, 1326339, 1347634, 1347635, 1347636, 1347637, 1357215, 1357216, 1357217, 1357219, 1357220, 1357221, 1357222, 1357223, 1357224, 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2. Do not eat it: Even if it looks and smells fine, do not consume this product.
3. Throw it away or return it: You can return the product to the store for a full refund.
4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
5. Report problems: Report any issues to the FDA's Safety Reporting Portal.