Exact FDA event identifier

Event 88570

9 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: August 30, 2021
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Exactech, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

9 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 9

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.

Z-0019-2022

Recall number: Z-0019-2022
Initiated: August 30, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Exactech, Inc.
Quantity: 242,397 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Code information

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, 1659797, 1659798, 1659799, 1659800, 1659801, 1704209, 1704210, 1704211, 1704212, 1786558, 1786559, 1786560, 1786561, 1786562, 1786563, 1786564, 1786565, 1797016, 1797017, 1797018, 1797019, 1797020, 1797021, 1797022, 1797023, 1797024, 1797025, 1797026, 1797027, 1797028, 1817561, 1817562, 1817563, 1817564, 1817565, 1817566, 1817567, 1817568, 1817569, 1817570, 1817571, 1817572, 1817573, 1842319, 1842320, 1842321, 1842324, 1842325, 1901249, 1901250, 1901251, 1901252, 1901253, 1901255, 1901256, 1901259, 1901260, 1901261, 1901262, 1901263, 1901264, 1901265, 1901266, 1901267, 1901268, 1901269, 1901270, 1901271, 1901272, 1901273, 1901274, 1901275, 1901276, 2266634, 2266635, 2266636, 2266638, 2276586, 2276587, 2276588, 2276589, 2397396, 2397397, 2397398, 2397399, 2397400, 2397401, 2397402, 2397403, 2397404, 2397405, 2425639, 2425640, 2425641, 2425642, 2425643, 2425644, 2425645, 2425646, 2425647, 2425648, 2425650, 2425651, 2425652, 2425653, 2425654, 2425655, 2425656, 2430257, 2430258, 2430259, 2430260, 2430261, 2430262, 2430263, 2430264, 2430265, 2615191, 2615192, 2615193, 2615194, 2615195, 2615196, 2615197, 2615198, 2615199, 2615200, 2653102, 2653103, 2653104, 2653105, 2653106, 2653107, 2653108, 2653109, 2653110, 2653111, 2653112, 2653113, 2653114, 2653115, 2653116, 2653117, 2653118, 2653119, 2653120, 2653121, 2653123, 2653124, 2653125, 2653126, 2653127, 2653128, 2653129, 2653130, 2653131, 3545584, 3545585, 3545586, 3545587, 3545588, 3545589, 3545590, 3545591, 3545592, 3545593, 3636693, 3636694, 3636695, 3636696, 3636697, 3636698, 3636699, 3636700, 3636701, 3636702, 3654361, 3654362, 3654363, 3654364, 3654365, 3654366, 3654367, 3654368, 3654369, 3654370, 3660720, 3660721, 3660722, 3660723, 3660724, 3781241, 3781242, 3781243, 3781244, 3781245, 3792869, 3792870, 3792871, 3792872, 3792873, 3809326, 3809327, 3809328, 3809329, 3809330, 4080806, 4080807, 4080808, 4080809, 4080810, 4080811, 4080812, 4080813, 4080814, 4080815, 4149218, 4149219, 4149220, 4149221, 4149222, 4175249, 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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1534799, 1534800, 1576758, 1576759, 1576760, 1576761, 1576762, 1576763, 1576764, 1576765, 1576766, 1576767, 1619204, 1619205, 1619206, 1619207, 1619208, 1619209, 1619210, 1619211, 1619212, 1619213, 1661516, 1661517, 1661518, 1661519, 1661520, 1661521, 1661522, 1661523, 1661524, 1661525, 1661526, 1661527, 1661528, 1661529, 1661530, 1673843, 1673844, 1673845, 1673846, 1673847, 1673848, 1673849, 1673850, 1673851, 1673852, 1693776, 1693777, 1693778, 1693779, 1693780, 1693781, 1693782, 1693783, 1693784, 1693785, 1791221, 1791222, 1791223, 1791224, 1791225, 1791226, 1791227, 1791228, 1791229, 1799118, 1799119, 1799120, 1799121, 1799122, 1799123, 1799124, 1799125, 1799126, 1799127, 1811412, 1811413, 1811414, 1811415, 1811416, 1811417, 1811418, 1811419, 1817798, 1817799, 1817800, 1817801, 1817802, 1817803, 1831528, 1831529, 1831530, 1831531, 1831533, 1831534, 1831535, 1831536, 1899925, 1899926, 1899927, 1899928, 1899929, 2255018, 2255019, 2255020, 2255021, 2255971, 2255972, 2255973, 2255974, 2255975, 2255976, 2306080, 2306081, 2306082, 2306083, 2306084, 2306085, 2306086, 2306087, 2306088, 2306089, 2306090, 2306091, 2306092, 2306093, 2370401, 2370402, 2370403, 2370404, 2370405, 2370406, 2370407, 2370408, 2370409, 2370410, 2398805, 2398806, 2398807, 2398808, 2398809, 2398810, 2398811, 2398812, 2398813, 2398814, 2398815, 2398816, 2398817, 2398818, 2398819, 2398820, 2398821, 2415553, 2415555, 2415556, 2415557, 2415558, 2415559, 2415560, 2415561, 2415562, 2454408, 2454409, 2454410, 2454411, 2454412, 2454413, 2454414, 2454415, 2454416, 2454417, 2509357, 2509358, 2509359, 2509360, 2551485, 2551486, 2551487, 2551488, 25

Distribution pattern

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, SINGAPORE, SPAIN, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TUNISIA, TURKEY, VENEZUELA .

device · product 2 of 9

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.

Z-0020-2022

Recall number: Z-0020-2022
Initiated: August 30, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Exactech, Inc.
Quantity: 2,774 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Code information

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, 2328963, 2328964, 2328965, 2328966, 2328968, 2509909, 2509911, 2566818, 2649854, 2692694, 2728962, 2728968, 2728971, 2728976, 2728977, 2728979, 2728980, 2728981, 2728988, 2728991, 3808095, 3808101, 3808110, 3808112, 3808116); 252-12-03 (10885862065773; 0764379, 0764380, 0764381, 0764382, 0764384, 0764385, 0764386, 0764387, 0764389, 0764390, 0764391, 0764392, 0764393, 0764394, 0764395, 0764396, 0764398, 0764400, 0764401, 0764402, 0764407, 0766178, 0766179, 0766180, 0766181, 0766182, 0766183, 0766185, 0766188, 0766189, 0766191, 0766193, 0766194, 0766195, 0766196, 0766198, 0766199, 0766200, 1152751, 1152756, 1152758, 1152759, 1152760, 1152763, 1152764, 1152765, 1152767, 1152768, 1152769, 1248425, 1248426, 1248427, 1248429, 1248430, 1248431, 1248432, 1248433, 1248434, 1248435, 1248437, 1248438, 1248439, 1248440, 1248441, 1248442, 1248443, 1248444, 1248445, 1248446, 1248447, 1248448, 1248449, 1248450, 1294270, 1294271, 1294272, 1294273, 1294274, 1294275, 1294276, 1294277, 1294278, 1294279, 1434902, 1434903, 1434904, 1434905, 1434906, 1434907, 1434908, 1434909, 1434910, 1510648, 1510649, 1510650, 1510651, 1526390, 1526391, 1526392, 1526393, 1545560, 1545561, 1548840, 1548841, 1548842, 1617606, 1617607, 1617608, 1617609, 1617610, 1617611, 1618554, 1618555, 1618556, 1618557, 1618558, 1706098, 1706099, 1706100, 1706101, 1706102, 1706104, 1706105, 1706106, 1706107, 1706108, 1706109, 1706110, 1778471, 1778472, 1778473, 1778474, 1778475, 1778476, 1778477, 1778478, 1778479, 1778480, 1778481, 1778482, 1778483, 1778484, 1778485, 1778486, 1778487, 1825147, 1825148, 1825149, 1825150, 1825151, 1825153, 1846127, 1846128, 1846129, 1846130, 1846131, 1846132, 1846133, 1846134, 1846135, 1846136, 1846137, 1933648, 1933649, 1933650, 1933651, 1936093, 1936094, 1936095, 2002988, 2002989, 2002990, 2002991, 2002992, 2002993, 2002994, 2049677, 2049678, 2049679, 2049680, 2049681, 2060180, 2087493, 2087494, 2087495, 2087496, 2087497, 2087498, 2087499, 2087500, 2087502, 2087503, 2087504, 2087506, 2087507, 2205053, 2205054, 2205055, 2205057, 2233544, 2233545, 2233548, 2233549, 2233550, 2233551, 2233553, 2233554, 2233555, 2233556, 2233557, 2233558, 2512172, 2512173, 2567163, 2567164, 2567165, 2567166, 2567168, 2567169, 2567171, 2567172, 2787069, 2787070, 2787071, 2787072, 2829262, 2829263, 2829264, 2906611, 2906612, 2906613, 2991360, 2991362, 2991363, 2991365, 3564018, 3564020, 3564021, 3564022, 3564023, 3564024, 3564025, 3564026, 3691658, 3808084, 3808085, 3808086, 3808089, 3808093, 4279265, 4279268, 4279270, 4279271, 4488796, 4677196, 5839504, 5839509, 5839510, 5839512, 5839513, 5839514, 5839517, 5839518, 5839519, 5839528, 5839531, 5839532, 5839533, 5839534, 5839535, 5839536, 5839537, 5839538, 5839539, 5839540, 5839541, 5839542, 5839543, 5839545, 5839549, 5839550, 5839557, 5839560); 252-12-04 (10885862065780; 1085902, 1085903, 1085904, 1085905, 1085906, 1085907, 1085908, 1085909, 1085911, 1085914, 1085915, 1085916, 1085917, 1085918, 1085919, 1085920, 1085921, 1085922, 1085923, 1085924, 1174118, 1174119, 1174120, 1174121, 1174122, 1174123, 1174124, 1174125, 1174126, 1174127, 1174129, 1174130, 1174131, 1174132, 1174133, 1174134, 1174136, 1174137, 1174139, 1174140, 1174141, 1174142, 1174143, 1174144, 1174145, 1174146, 1174147, 1174148, 1174149, 1174150, 1174151, 1174152, 1174153, 1174154, 1174155, 1174156, 1174157, 1174158, 1174159, 1174160, 1174161, 1174162, 1174163, 1174164, 1174165, 1174166, 1174168, 1174169, 1174170, 1174171, 1544907, 1544908, 1544909, 1544910, 1600619, 1600620, 1600621, 1600622, 1600623, 1600624, 1600625, 1600626, 1600627, 1600628, 1600629, 1603583, 1603584, 1603585, 1603586, 1603587, 1603588, 1603589, 1603590, 1603591, 1603592, 1603593, 1603594, 1603595, 1603596, 1603597, 1838244, 1838245, 1838247, 1838248, 1838250, 1838251, 1838252, 1838253, 1838254, 1838255, 1838256, 1838257, 1838258, 1838259, 1838260, 1838261, 1876049, 1876050, 1876051, 1876052, 1876053, 1876054, 1876055, 1876056, 1876057, 1876058, 1877196, 1877197, 1877198, 1877199, 1877200, 1877201, 1877203, 1877204, 1877205, 1877206, 1877207, 1877209, 1877210, 2080039, 2080040, 2080041, 2080042, 2080043, 2080044, 2080048, 2080049, 2080050, 2080051, 2204986, 2204987, 2235110, 2235111, 2235112, 2235113, 2235114, 2235115, 2235116, 2235117, 2235118, 2235119, 2235121, 2235122, 2235124, 2567173, 2567174, 2742317, 2742318, 2742319, 2742320, 2742321, 2742322, 2742323, 2892691, 2892692, 2892693, 2892694, 2892695, 2980254, 2980255, 2980256, 2980257, 2980258, 2980259, 2980260, 2980262, 2980263, 2980264, 2980265, 2980266, 2980267, 2995492, 2995494, 2995496, 2995498, 2995500, 2995502, 3624142, 3624143, 3624145, 3624148, 3624150, 3728981, 3755632, 3791754, 3791756, 3791757, 3791758, 3791759, 3971565, 3971566, 3971567, 3971568, 3971569, 3971570, 4019996, 4019997, 4019998, 4020000, 4058269, 4058270, 4058271, 4298553, 4298556, 4298557, 4298558, 4298560, 4298561, 4298563, 4298564, 4298565, 4298566, 4719674, 4719677); 252-12-05 (10885862065797; 0764354, 0764356, 0764358, 0764359, 0764360, 0764361, 0764363, 0764364, 0764366, 0764367, 0764368, 0764369, 0764371, 0764372, 0776484, 0776485, 0776486, 0776487, 0776489, 0776491, 0776492, 0776497, 0776499, 0776500, 0776501, 0776502, 0776505, 0776506, 0776507, 0776508, 1344152, 1344153, 1344155, 1344156, 1344157, 1344158, 1344159, 1344160, 1344161, 1413174, 1413175, 1413176, 1413177, 1429614, 1429615, 1429616, 1429617, 1429618, 1429619, 1429620, 1429621, 1429622, 1429623, 1443143, 1443144, 1443145, 1443146, 1443147, 1513762, 1513763, 1513764, 1513765, 1513766, 1513767, 1513768, 1513769, 1513770, 1513771, 1722792, 1722794, 1722796, 1722797, 1722799, 1722800, 1722802, 1722803, 1722804, 1722805, 1722806, 1786482, 1786483, 1786485, 1786486, 1786487, 1786488, 1786492, 1786494, 1786495, 1786496, 1845431, 1845433, 1845435, 1932090, 1932091, 1932092, 1932093, 1932094, 2039276, 2049683, 2138747, 2138748, 2138749, 2138750, 2138751, 2138752, 2152317, 2152318, 2152319, 2152320, 2152322, 2236090, 2236091, 2236094, 2236095, 2287646, 2287648, 2287649, 2287650, 2351082, 2351083, 2351084, 2464982, 2464983, 2567177, 2782410, 2782411, 2796910, 2796911, 2796912, 2796913, 2796915, 2796916, 2877828, 2877831, 2965401, 2965402, 2965403, 2991358, 3122647, 3122648, 3122649, 3122650, 3546828, 3546829, 3546831, 3669732, 3669733, 3669735, 3669736, 3669737, 3699151, 3699152, 3808117, 3808118, 3808119, 3808120, 3808122, 4005870, 4005871, 4005872, 4005873, 4005874, 4046964, 4046965, 4133012, 4133014, 4133015, 4133017, 4133020, 4133021, 4133024, 4133028, 4133030, 4133032, 4133033, 4133034, 4133035); 252-12-06 (10885862065803; 0764251, 0764255, 0764256, 0764258, 0764260, 0764261, 0764264, 0764265, 0764267, 0764268, 1527895, 1704849, 1704850, 1704851, 1704853, 1704855, 1705430, 1705431, 1774436, 1774437, 1774438, 1774439, 1790515, 1790521, 1790522, 1790523, 1790524, 1790525, 1790526, 2502380, 2535994, 2535995, 2535996, 2535997, 2535998, 2535999, 2536000, 2566819, 2566820, 2566821, 2742308, 2742309, 2742310, 2742311, 2742312, 2742314, 2742315, 2742316, 2906750, 2972415, 2972418, 2972419, 3669846, 3728978, 3792365, 3808124, 3808125, 3808126, 3808127, 3808131, 3965029, 3965030, 3965031, 3965032, 3965033, 3965034, 3965035, 3965036, 4093360, 4093361, 4093362, 4093363, 4093364, 4093365, 4093366, 4093367, 4093368, 4093369, 4093370, 4093372, 4093373, 4093374, 4149809, 4149813, 4149820, 4149821, 4149822); 252-13-01 (10885862065810; 0757154, 0757157, 0757162, 0757164, 0757167, 0757168, 0757169, 0757172, 0757173, 0779683, 0779687, 0779688, 0779690, 0779695, 0779698, 0779700, 0779702, 0779704, 0779705, 0779706, 1444543, 1444544, 1444546, 1444547, 1454184, 1637927, 1637931, 1637932, 1637934, 1637941, 1772248, 1772249, 1772250, 1772251, 1772252, 1772253, 1772254, 1772259, 1772260, 1772262, 1772265, 1772267, 1772268, 1772269, 1772270, 1772271, 1772273, 1997498, 2025207, 2025209, 2025210, 2025211, 2059074, 2059076, 2059077, 2059082, 2059083, 2350825, 2350826, 2350828, 2350829, 2446052, 2446054, 2446057, 2446058, 3669847, 3669848, 3728983, 3728984, 3808079, 3808080, 4361052); 252-13-02 (10885862065827; 1019275, 1019276, 1019277, 1019278, 1019279, 1019280, 1019282, 1019283, 1019284, 1019285, 1019286, 1019287, 1019288, 1019289, 1019290, 1019291, 1019292, 1019294, 1102287, 1102288, 1102289, 1102290, 1102291, 1102294, 1102296, 1102297, 1102299, 1102303, 1102304, 1102305, 1102306, 1102308, 1102309, 1107608, 1107610, 1107611, 1107613, 1107615, 1107616, 1107617, 1107618, 1107620, 1107621, 1107626, 1107627, 1107629, 1107630, 1107631, 1454672, 1454673, 1454674, 1601453, 1601454, 1601455, 1601456, 1601458, 1601459, 1601461, 1603598, 1603599, 1603600, 1603601, 1603602, 1603603, 1603605, 1603606, 1603607, 1704431, 1704432, 1704433, 1704434, 1704435, 1704436, 1704438, 1704439, 1704440, 1784663, 1838357, 1838358, 1838359, 1838361, 1838780, 1838781, 1838782, 1856535, 1856536, 1856537, 1856539, 1856540, 1856541, 1856542, 1856543, 1856544, 1927753, 1927754, 1927756, 1927758, 1927759, 2183886, 2183888, 2183889, 2377737, 2377738, 2377742, 2464981, 2512167, 2512170, 2512171, 2887563, 2887564, 2887570, 2887571, 2887575, 2887580, 2887585, 3792363, 3808148, 3808153, 3808154, 3808155, 3808159); 252-13-03 (10885862065834, 0816528, 0816529, 0816530, 0816531, 0816532, 0816533, 0816534, 0816535, 0816537, 0816538, 0816539, 0816540, 0816541, 0816542, 0816543, 0816544, 0816545, 0816546, 0816548, 0816549, 0816550, 0816552, 1103826, 1103827, 1103828, 1103829, 1103830, 1103831, 1103832, 1103833, 1103834, 1177565, 1177567, 1177568, 1177569, 1177570, 1177571, 1177572, 1177573, 1177575, 1177576, 1177578, 1177579, 1177580, 1177581, 1177584, 1177585, 1177586, 1177587, 1177588, 1177589, 1177590, 1177591, 1177592, 1177593, 1177594, 1303849, 1303850, 1303851, 1303852, 1303853, 1303854, 1303855, 1303856, 1303857, 1303858, 1303859, 1303860, 1303861, 1303862, 1303863, 1457350, 1457351, 1457352, 1457353, 1457354, 1548854, 1548855, 1548856, 1548857, 1611609, 1611610, 1611611, 1611612, 1611613, 1611614, 1611615, 1611616, 1611617, 1611618, 1611619, 1611620, 1611621, 1705501, 1705502, 1705503, 1705504, 1705505, 1705506, 1705507, 1705508, 1705509, 1705510, 1705511, 1705512, 1705513, 1807587, 1807589, 1807591, 1807592, 1807593, 1807594, 1807595, 1824050, 1824051, 1824052, 1824054, 1845723, 1845724, 1845725, 1845726, 1845727, 1877151, 1877152, 1877153, 1877154, 1877155, 1897934, 1897935, 1897936, 1897938, 1926313, 1926314, 1926315, 1926316, 1926317, 1992549, 1992550, 1992551, 1992552, 1992553, 2002983, 2002984, 2002986, 2002987, 2049672, 2049673, 2049674, 2049676, 2170671, 2170672, 2170673, 2170675, 2170676, 2170677, 2204946, 2204947, 2204948, 2204949, 2204950, 2204951, 2204952, 2204954, 2204955, 2281013, 2281014, 2281015, 2281016, 2281017, 2281018, 2281019, 2281020, 2281021, 2281022, 2387169, 2387170, 2387173, 2387174, 2387175, 2387176, 2387178, 2387179, 2387180, 2387181, 2387182, 2387183, 2387184, 2387185, 2567178, 2567179, 2567180, 2742356, 2742357, 2742359, 2742360, 2742361, 2742362, 2742363, 2834200, 2834201, 2834202, 2834203, 2834204, 2834205, 2887592, 2887594, 2887595, 2887597, 2887598, 2980252, 2980253, 3124817, 3124818, 3124819, 3124820, 3589948, 3589949, 3589950, 3589951, 3589954, 3589957, 3623858, 3623859, 3623860, 3623861, 3623862, 3623863, 3623864, 3791749, 3791752, 3791753, 4088131, 4088133, 4088134, 4288671, 4288672, 4288673, 4288675, 4288677, 4288679, 4288681, 4288682, 4288683, 4288684, 4288685, 4288686, 4288691); 252-13-04 (10885862065841; 1032302, 1032303, 1032304, 1032305, 1032306, 1032307, 1032308, 1032309, 1032310, 1032311, 1032312, 1032313, 1032314, 1032315, 1032316, 1032317, 1032318, 1032320, 1032322, 1032324, 1032325, 1032326, 1184215, 1184216, 1184217, 1184218, 1184219, 1184220, 1184221, 1184222, 1184223, 1184224, 1184225, 1184227, 1184229, 1184230, 1184231, 1184232, 1184233, 1184234, 1184235, 1184236, 1184237, 1184238, 1406504, 1406505, 1406506, 1406507, 1406508, 1406509, 1406510, 1406511, 1406512, 1406513, 1441232, 1441233, 1441234, 1441235, 1441236, 1453966, 1453967, 1453968, 1453969, 1453970, 1466984, 1466985, 1526558, 1526559, 1544911, 1544912, 1544913, 1544914, 1544915, 1548835, 1548836, 1548837, 1548838, 1548839, 1619057, 1619058, 1619059, 1619060, 1619061, 1619062, 1619063, 1619064, 1619065, 1619066, 1725891, 1725892, 1725893, 1725894, 1725895, 1725897, 1725899, 1725900, 1725901, 1725902, 1725903, 1725904, 1725905, 1725906, 1725907, 1725908, 1725909, 1725910, 1794392, 1794393, 1794394, 1794395, 1794396, 1794397, 1794398, 1794399, 1794400, 1794401, 1794402, 1794403, 1794404, 1894970, 1896281, 1896282, 1896283, 1896284, 1926194, 1926195, 1926196, 1926197, 1926198, 1926199, 1926200, 1926201, 1936083, 1936084, 1936085, 1936088, 1936089, 1936090, 1936091, 1936092, 2100324, 2100325, 2100326, 2100327, 2100328, 2100329, 2100330, 2100332, 2100333, 2257670, 2257671, 2257672, 2257674, 2257675, 2257676, 2257677, 2257678, 2257679, 2329609, 2329610, 2329611, 2329612, 2329613, 2329614, 2329615, 2329616, 2567181, 2567182, 2567183, 2567184, 2567185, 2782405, 2782406, 2782407, 2787081, 2787082, 2787083, 2787084, 2787085, 2845606, 2845607, 2845609, 2845610, 2845612, 2980268, 2980269, 2980270, 2980271, 2980272, 2980273, 2980275, 2980276, 2980277, 2980280, 2980281, 2980282, 2995482, 2995483, 2995484, 2995485, 2995487, 2995488, 3624128, 3624129, 3624130, 3624133, 3624134, 3624137, 3776795, 3776796, 3776797, 3952015, 3952016, 3952017, 3952018, 3952019, 3952020, 3952023, 3952024, 4020002, 4020003, 4020004, 4020006, 4058263, 4058264, 4058265, 4058266, 4058267, 4058268, 4418379, 4418380, 4418383, 4418384, 4418385, 4719663, 4719664, 4719665, 4719666, 4719667, 4719668, 4719669, 4719670, 4719671, 4719672, 4719673); 252-13-05 (10885862065858, 0759432, 0766508, 0766509, 0766510, 0766512, 0766513, 0766514, 0766515, 0766516, 0766517, 0766519, 0766520, 0766522, 0766524, 0766525, 0766526, 0766528, 0766531, 0771768, 0771771, 0771772, 0771773, 0771774, 0771776, 0771781, 0771784, 1332887, 1332888, 1332889, 1332890, 1332891, 1332892, 1332893, 1332894, 1332895, 1332896, 1332897, 1332898, 1332899, 1332900, 1332901, 1332902, 1332904, 1332905, 1332906, 1332907, 1332908, 1332910, 1332911, 1637864, 1637865, 1637866, 1637867, 1637868, 1637869, 1637870, 1637871, 1637873, 1637874, 1637875, 1637876, 1637877, 1637878, 1637879, 1637880, 1637881, 1637882, 1637883, 1637884, 1637886, 1637887, 1637888, 1860543, 1860546, 1860547, 1867301, 1867302, 1867303, 1867304, 1867305, 1867306, 1867307, 1867308, 1867309, 1867310, 1933642, 1933643, 1933644, 1933645, 1933646, 2079592, 2079593, 2079594, 2079595, 2162360, 2162361, 2162362, 2162363, 2162364, 2162365, 2162366, 2162367, 2189315, 2208107, 2208108, 2208109, 2208110, 2208112, 2208113, 2290302, 2290303, 2290305, 2290306, 2345879, 2345880, 2345881, 2345882, 2345883, 2345884, 2387619, 2387620, 2387622, 2387623, 2387624, 2387626, 2387627, 2387628, 2567187, 2730001, 2730002, 2730003, 2730004, 2782332, 2782333, 2782335, 2803106, 2803108, 2803109, 2803110, 2803111, 2803112, 2803113, 2877824, 2877825, 2877827, 2887599, 2887600, 2972268, 2991366, 2991367, 2991369, 2991371, 3563760, 3563762, 3563763, 3669961, 3669962, 3669964, 3730537, 3730538, 3730539, 3786776, 3786777, 3786779, 3786780, 3808133, 3808134, 3808136, 3808137, 3808138, 3808139, 3808141, 3808143, 4039840, 4039843, 4039845, 4279323, 4279327, 4279329, 4279331, 4279333, 4279335, 4279336, 4279338); 252-13-06 (10885862065865; 0764224, 0764226, 0764227, 0764230, 0764231, 0764237, 0764238, 0764241, 0764242, 0764245, 0764247, 1455010, 1689750, 1689751, 1689752, 1717174, 1717175, 1717176, 1717177, 1717178, 1717180, 1717181, 1717183, 1774476, 1774477, 1774478, 1774479, 1774480, 1836619, 1836620, 1836621, 1836622, 1836623, 1850667, 1850668, 1850669, 1850670, 1932007, 1932008, 1932009, 1932010, 2512175, 2742324, 2742325, 2742326, 2742328, 2742329, 2742330, 2742331, 2742333, 2742334, 2742335, 2906755, 2906756, 2906757, 3359313, 3546825, 3546826, 3624172, 3624173, 3624174, 3777081, 3777082, 3777083, 3791763, 3791764, 3791766, 3791767, 3867775, 3867776, 3879613, 3879614, 3906832, 3906833, 3947881, 3971571, 3976717, 3991681, 4005877, 4020007, 4020008, 4046967, 4046968, 4148242, 4148244, 4148245, 4148246, 4148248, 4148249, 4148250, 4148251, 4148252, 4148256, 4148259, 4148262, 4148263, 4148264, 4148265, 4148268, 4148269, 4148271); 252-22-01 (10885862065872; 0754625, 0754626, 0754628, 0754629, 0754631, 0754633, 0754634, 0754635, 0754636, 0754637, 0754638, 0754643, 1235158, 1235159, 1235160, 1235162, 1235164, 1235165, 1235169, 1235171, 1235176, 1235177, 1235178, 1235180, 1235184, 1235185, 1235186, 1235190, 1235191, 1235192, 1235194, 1235195, 1235196, 1235203, 1235204, 1235214, 1235217, 2116253, 2162371, 2162372, 2350994, 2351002, 2758663, 2758665, 2758666, 2758668, 2758672, 2758678, 2759610, 2759611, 2759613, 3664711, 3664712); 252-22-02 (10885862065889; 1102708, 1102713, 1102717, 1102720, 1102721, 1102722, 1102723, 1102725, 1102726, 1102727, 1102728, 1343996, 1343997, 1343998, 1343999, 1344001, 1344002, 1344003, 1344004, 1455015, 1455016, 1455017, 1689735, 1689737, 1689738, 1689739, 1689740, 1689741, 1689742, 1689743, 1689747, 1689748, 1839444, 1839445, 1839446, 1839447, 1839448, 1844107, 1894955, 1894956, 1894957, 2168369, 2168373, 2388628, 2863308, 2863310, 2863311, 2863315, 2863318, 3664722, 3664723, 3664725, 3670106, 3684112, 4221560, 4221567, 4221571); 252-22-03 (10885862065896, 1088653, 1088654, 1088656, 1088657, 1088658, 1088659, 1088662, 1088663, 1088664, 1088668, 1088669, 1249542, 1249545, 1249546, 1249547, 1249548, 1249549, 1249550, 1249551, 1249556, 1249558, 1249559, 1249560, 1249561, 1249563, 1249564, 1649379, 1649380, 1649381, 1649382, 1649384, 1649385, 1649386, 1649387, 1649388, 1649390, 1649391, 1775470, 1775471, 1775472, 1775473, 1775474, 1839858, 1839859, 1839860, 1839861, 1839862, 1858821, 1858822, 1858823, 1858824, 1858825, 1896188, 1896189, 1896191, 1897113, 1897116, 1897117, 1936111, 1936115, 2351066, 2351068, 2351069, 2351070, 2351072, 2351076, 2351079, 2877818, 2877820, 2877821, 3358170, 3358179, 3664737, 3670105, 4221573, 4221575, 4221578, 4221581, 4221582, 4221584, 4221587, 4221588, 4221590, 4221592, 4221595, 4221597, 4221598, 4221599, 4221601); 252-22-04 (10885862065902, 0753334, 0771683, 0771684, 0771685, 0771686, 0771687, 0771688, 0771689, 0771692, 0771693, 0771695, 0771698, 0771699, 0771701, 0771704, 0771705, 1139403, 1139404, 1139405, 1139406, 1139408, 1139409, 1139410, 1139411, 1139412, 1139415, 1139416, 1139417, 1139420, 1139421, 1139423, 1139424, 1416363, 1416364, 1416365, 1416366, 1416367, 1443200, 1443201, 1443203, 1453957, 1453958, 1707020, 1707021, 1707022, 1707024, 1707025, 1707027, 1707028, 1707029, 1772014, 1772015, 1772016, 1772017, 1772018, 1772019, 1822167, 1822168, 1822169, 1822170, 1822171, 1822172, 1822173, 1822174, 1822175, 1822176, 1839528, 1845397, 1845398, 1845400, 1845404, 1845405, 1999773, 1999774, 2058866, 2058867, 2058868, 2058871, 2058873, 2204936, 2204939, 2204942, 2540093, 2540094, 2540095, 2540097, 2540098, 2540099, 2577258, 2796921, 2906758, 2906760, 2906762, 3624089, 3809355, 4093902, 4093904, 4093907, 4093909, 4288641, 4288642, 4288643, 4288644, 4288645, 4288650, 4288651, 4288653, 4288654, 4288660); 252-22-05 (10885862065919; 0764412, 0764413, 0764417, 0764418, 0764422, 0764424, 0764425, 0764426, 0764427, 0764428, 0764429, 0764433, 1161572, 1161573, 1161575, 1237561, 1237562, 1237563, 1237564, 1237565, 1237568, 1237573, 1237575, 1237576, 1237577, 1237579, 1706966, 1706968, 1706969, 1725876, 1725877, 1725878, 1725882, 1725883, 1725884, 1725888, 1725889, 1848135, 1848137, 1848139, 1848140, 1848141, 2300138, 2300139, 2300140, 2300141, 2300142, 2335598, 2335599, 2335601, 2388374, 2388375, 2388377, 2388379, 2388380, 2567191, 2567192, 2713119, 2713120, 2713121, 2713123, 2713125, 2713126, 2782331, 2787092, 2787093, 2787094, 2877823, 2972414, 3543922, 3546846, 3635680); 252-22-06 (10885862065926, 0764201, 0764202, 0764203, 0764218, 0764223, 1722669, 1722673, 1722675, 1722677, 1796929, 1796931, 1796934, 1796936, 1838482, 1838483, 1846139, 1846140, 1846141, 1846143, 2165648, 2165649, 2165652, 2388623, 2388624, 2388625, 2388626, 2742343); 252-23-01 (10885862065933; 0757809, 0757810, 0757811, 0757813, 0757816, 0757817, 0757823, 0757825, 1139427, 1139428, 1139430, 1139431, 1139433, 1139435, 1139436, 1139438, 1139440, 1139442, 1139443, 1139445, 1139446, 1139448, 1458481, 1704859, 1765611, 1765612, 1765614, 1779510, 1779511, 1779512, 1779513, 1779515, 1779518, 1927737, 1927738, 1927739, 1927747, 2566828, 2793214, 2793216, 2793218, 2972411, 3624029, 3635664, 3664731, 3677964, 3677965, 3677970, 3677971); 252-23-02 (10885862065940; 1105678, 1105679, 1105682, 1105683, 1105685, 1105686, 1105688, 1105689, 1105692, 1105693, 1105694, 1105700, 1105701, 1416341, 1416343, 1416344, 1458477, 1637148, 1637149, 1637150, 1637151, 1637906, 1637908, 1637909, 1637910, 1637911, 1637912, 1637913, 1637916, 1637917, 1769924, 1769925, 1769926, 1769927, 1769929, 1769930, 1769931, 1839863, 1845257, 1845258, 1845259, 1845261, 1845263, 1845264, 1905140, 1905141, 1905142, 1905143, 1905144, 1927764, 2059085, 2059089, 2059091, 2059094, 2388367, 2388371, 2787080, 3624166, 3624167, 3624168, 3699141, 3699142, 4211364, 4211370, 4211384); 252-23-03 (10885862065957; 0742241, 0742243, 0742245, 0742253, 0742254, 0742255, 0742256, 0742257, 0742258, 0742259, 0742264, 0742266, 0742269, 0779777, 1157151, 1157152, 1157153, 1157154, 1157156, 1157158, 1157160, 1157161, 1157162, 1157164, 1157165, 1157166, 1157167, 1157168, 1157172, 1157173, 1443148, 1443150, 1443151, 1443152, 1701768, 1701769, 1701771, 1701772, 1701773, 1701774, 1701776, 1701777, 1741523, 1741524, 1741526, 1741527, 1741528, 1741529, 1741530, 1741531, 1741532, 1741533, 1741534, 1741535, 1741536, 1741537, 1741538, 1741539, 1741540, 1741541, 1741542, 1741543, 1741544, 1741545, 1741546, 1855733, 1855735, 1855736, 1855737, 1896405, 1896406, 1896407, 1896408, 1896409, 1926202, 1926203, 1926204, 1926205, 1926206, 2119809, 2119810, 2119811, 2119812, 2163600, 2163604, 2163607, 2163608, 2282405, 2282406, 2388613, 2388615, 2388619, 2388620, 2388621, 2829279, 2829282, 2965411, 2965414, 3520578, 3520579, 3520580, 3589940, 3623850, 3623851, 3792532, 4058262, 4148277, 4148278, 4148281, 4148283, 4148284, 4148285, 4148286, 4148287, 4148289, 4148290, 4148291, 4148292, 4148293, 4148294, 4148295, 4148296, 4148299, 5839564); 252-23-04 (10885862065964; 1141051, 1141052, 1141055, 1141056, 1141057, 1141058, 1141059, 1141061, 1141062, 1141063, 1141064, 1141065, 1141066, 1141067, 1141068, 1141070, 1141071, 1141072, 1141073, 1141074, 1434898, 1434899, 1434900, 1434901, 1453962, 1453963, 1453964, 1632745, 1632746, 1632749, 1632750, 1632751, 1632753, 1632754, 1632757, 1632759, 1706960, 1706961, 1706962, 1706963, 1709948, 1709949, 1709950, 1709951, 1709952, 1777266, 1839529, 1839530, 1839531, 1839532, 1839533, 1844761, 1844762, 1844763, 1844764, 1858816, 1858817, 1858818, 1858819, 1858820, 1923303, 1923304, 1923305, 1923306, 1923307, 1923308, 1923309, 1923311, 1941007, 1941008, 1941009, 2351045, 2351047, 2351048, 2351049, 2351056, 2351057, 2351058, 2351059, 2351060, 3589945, 3670112, 4052828, 4052832, 4052834, 4325986, 4325988); 252-23-05 (10885862065971; 0759431, 0766124, 0766126, 0766130, 0766131, 0766133, 0766134, 0766136, 0766137, 0766139, 0766141, 0766142, 0766146, 1159234, 1159235, 1159236, 1159237, 1159247, 1159248, 1159249, 1159250, 1441237, 1441238, 1441239, 1441240, 1453953, 1453954, 1453955, 1453956, 1741361, 1741364, 1741365, 1741366, 1741368, 1741369, 1741370, 1741371, 1741374, 1741379, 1844814, 1844815, 1844816, 1932011, 1932013, 1932014, 1932015, 2243133, 2243134, 2243137, 2243138, 2243140, 2243141, 2345641, 2345642, 2345643, 2345644, 2345645, 2345648, 2345649, 2345650, 2345651, 2502108, 2566830, 2742341, 2782327, 2782328, 2803115, 2803122, 3546765, 3546766, 3623857); 252-23-06 (10885862065988; 0763507, 0763510, 0763511, 0763512, 0763513, 0763514, 0763517, 0763523, 0763524, 1725300, 1725301, 1725302, 1725303, 1725304, 1725305, 1725306, 1725308, 1725309, 1725310, 1725312, 1725313, 1725314, 1725315, 1848127, 1848129, 2536001, 2536003, 2536004, 2536007, 2536009, 2536010, 2566836, 2566837, 2566838, 2787100, 2787101, 2829284, 3808171, 3808172, 3808176);

Distribution pattern

device · product 3 of 9

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 + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Z-0021-2022

Recall number: Z-0021-2022
Initiated: August 30, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Exactech, Inc.
Quantity: 109,787 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Code information

a. Item Number (Device Identifier; Serial number(s)): 02-012-35-0009 (10885862001641; 1678465, 1678471, 1678474, 1678481, 1957753, 2006036, 2006037, 2013812, 2043308, 2092688, 2554898, 2573058, 4705904); 02-012-35-0011 (10885862001658; 1678302, 1678309, 1678312, 1963089, 2019801, 2104502, 2104504, 2363227, 2666629, 3809531, 3809537, 4760880); 02-012-35-0013 (10885862001665; 1678446, 1678450, 2092581, 2092584, 2523130); 02-012-35-0015 (10885862001672; 1677680); 02-012-35-1009 (10885862001689; 1393427, 1393428, 1393429, 1393430, 1393431, 1393432, 1393433, 1393435, 1393436, 1393437, 1393438, 1393439, 1393440, 1393441, 1398561, 1398562, 1398563, 1398564, 1398568, 1398569, 1398573, 1398575, 1398578, 1398579, 1398580, 1398581, 1398582, 1398583, 1398584, 1398586, 1398587, 1398588, 1398589, 1398590, 1469287, 1469288, 1469289, 1469290, 1469291, 1469292, 1469293, 1469294, 1469296, 1472031, 1472032, 1472033, 1472034, 1472035, 1472038, 1472040, 1472042, 1472043, 1472044, 1472046, 1472047, 1486523, 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5263413, 5263414, 5263415, 5263416, 5838383, 5838384, 5838385, 5838387, 5838389, 5838390, 5838391, 5838394, 5915272, 5915273, 5915276, 5915277, 5915278, 5930747, 5930748, 5930749, 5930751, 5930754, 5930755, 5930756, 6015750, 6015751, 6015752, 6015754, 6015756, 6015759, 6015760, 6015761, 6015762, 6015767, 6015768, 6060848, 6060849, 6060850, 6060851, 6060852, 6060853, 6060856, 6060857, 6060858, 6060860, 6060861, 6060862, 6060863, 6060864, 6060865, 6060866, 6062568, 6062570, 6062576, 6062583, 6062584, 6062585, 6062587, 6082487, 6082488, 6082490, 6082492, 6082496, 6082497, 6082498, 6082499, 6082501, 6082502, 6082503, 6082504, 6082506, 6194312, 6194315, 6194316, 6194319, 6194320, 6194321, 6194326, 6194328, 6194329, 6328094, 6328095, 6328097, 6328098, 6328099, 6328100, 6328101, 6328102, 6328103, 6328105, 6328106, 6328108, 6328109, 6328110, 6328111, 6357278, 6357281, 6357283, 6357286, 6357290, 6357293, 6357295, 6364461, 6364462, 6364464, 6364466, 6364476, 6364478, S052101, S052107, S052108, S052109, S052110, S052114, S052117, S052119, S053565, S053570, S055584, S055588, S055595, S055601, S063290, S202545, S202547, S202553, S202557, S202558, S202575); 02-012-35-1011 (10885862001696; 1397902, 1397904, 1397906, 1397907, 1397908, 1397910, 1397911, 1397913, 1397914, 1397915, 1397916, 1397917, 1397918, 1397919, 1397920, 1397921, 1397922, 1397923, 1397924, 1397925, 1397926, 1397927, 1397928, 1397929, 1397931, 1452167, 1452168, 1452170, 1452171, 1452172, 1452173, 1452176, 1452177, 1452179, 1452180, 1452181, 1452182, 1452183, 1452184, 1452185, 1452186, 1453253, 1453254, 1453255, 1453256, 1453257, 1453258, 1453259, 1453260, 1471448, 1471450, 1471451, 1471452, 1471453, 1471454, 1471455, 1471456, 1471457, 1476384, 1476385, 1476386, 1476389, 1476390, 1476391, 1476392, 1476393, 1485328, 1485329, 1485330, 1485333, 1485334, 1485336, 1485337, 1485338, 1485339, 1485340, 1485341, 1485342, 1485343, 1485345, 1485347, 1485348, 1485349, 1485350, 1485351, 1485352, 1485353, 1485354, 1485355, 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2442147, 2442148, 2442149, 2442150, 2442151, 2442152, 2442153, 2442155, 2442157, 2442160, 2442161, 2442162, 2442163, 2442165, 2442166, 2483884, 2483885, 2483886, 2483887, 2483889, 2483890, 2483893, 2483894, 2483895, 2483896, 2483897, 2483901, 2483902, 2507686, 2507687, 2507689, 2507690, 2507691, 2507692, 2507693, 2507694, 2507695, 2507696, 2507698, 2507699, 2507700, 2507701, 2507702, 2507703, 2507705, 2523148, 2523150, 2523151, 2523152, 2523154, 2523155, 2523156, 2523157, 2523158, 2523160, 2523162, 2523163, 2523164, 2523165, 2523167, 2695348, 2695349, 2695350, 2695351, 2695352, 2695353, 2695355, 2695356, 2695357, 2695358, 2695359, 2695360, 2695361, 2695362, 2695363, 2695364, 2695365, 2695366, 2695367, 2841177, 2841179, 2841180, 2841181, 2841182, 2841183, 2841185, 2841186, 2841187, 2841188, 2841190, 2841191, 2841192, 2841193, 2841194, 2841195, 2882671, 2882672, 2882673, 2882674, 2882675, 2882676, 2882677, 2882678, 2882679, 2882680, 2882682, 2882683, 2882684, 2882685, 2882686, 2882687, 2882688, 2882690, 2901430, 2901431, 2901432, 2901433, 2901434, 2901435, 2901437, 2901438, 2901439, 2901440, 2901441, 2901443, 2901444, 2901445, 2901446, 2901447, 2901448, 2901449, 2932083, 2932084, 2932085, 2932086, 2932087, 2932088, 2932089, 2932090, 2932091, 2932092, 2932093, 2932094, 2932095, 2932096, 2932097, 2932098, 2932099, 2932100, 2932102, 2953793, 2953794, 2953795, 2953796, 2953797, 2953798, 2953799, 2953800, 2953801, 2953802, 2953803, 2953807, 2953808, 2953809, 2953810, 2953811, 2953812, 3001928, 3001931, 3001932, 3001933, 3001934, 3001935, 3001936, 3001937, 3001938, 3001939, 3001940, 3001941, 3001942, 3001943, 3001944, 3001945, 3001946, 3594163, 3594164, 3594165, 3594166, 3594167, 3594168, 3594169, 3594170, 3594171, 3594172, 3594173, 3594174, 3594175, 3594176, 3594177, 3594178, 3594179, 3594180, 3594181, 3594182, 3594183, 3594184, 3594186, 3594187, 3594188, 3594189, 3594190, 3594191, 3594192, 3594193, 3594194, 3594195, 3594196, 3594197, 3594198, 3594199, 3594200, 3594201, 3594202, 3628203, 3628204, 3628205, 3628206, 3628207, 3628208, 3628210, 3628211, 3628212, 3628213, 3628214, 3628215, 3628216, 3628217, 3628218, 3628219, 3628220, 3628221, 3628222, 3630862, 3630863, 3630864, 3630865, 3630866, 3663344, 3663347, 3663348, 3663349, 3663350, 3663351, 3663352, 3663353, 3663354, 3663356, 3663357, 3663358, 3663359, 3663360, 3663362, 3663363, 3672577, 3672578, 3672580, 3672581, 3672582, 3672583, 3672584, 3672585, 3672586, 3672587, 3672588, 3672589, 3672590, 3672591, 3672592, 3672593, 3672594, 3672595, 3704909, 3704910, 3704911, 3704912, 3704914, 3704915, 3704916, 3704917, 3704918, 3704922, 3730564, 3730565, 3730566, 3730567, 3730568, 3730569, 3730570, 3730571, 3730572, 3730573, 3730574, 3730575, 3730576, 3730577, 3730578, 3730579, 3730580, 3730581, 3730582, 3730583, 3759378, 3759379, 3759380, 3759381, 3759382, 3759383, 3759384, 3759385, 3759386, 3759387, 3759388, 3759389, 3759390, 3759391, 3759392, 3759393, 3759394, 3759395, 3759396, 3759397, 3779772, 3779773, 3779774, 3779775, 3779776, 3779777, 3779778, 3779779, 3779780, 3779781, 3779782, 3779783, 3779784, 3779785, 3779786, 3779788, 3811231, 3811232, 3811233, 3811234, 3811235, 3811236, 3811237, 3811238, 3811239, 3811240, 3811241, 3811243, 3811244, 3811245, 3811246, 3811247, 3811248, 3811249, 3811250, 3870411, 3870413, 3870414, 3870415, 3870416, 3870417, 3870419, 3870421, 3870422, 3870423, 3870424, 3870425, 3870426, 3870428, 3870429, 3870430, 3870431, 3870433, 3870434, 3870435, 3870437, 3870438, 3870439, 3870440, 3870441, 3870443, 3870444, 3870445, 3870446, 3870447, 3870448, 3907262, 3907263, 3907264, 3948694, 3948696, 3953279, 3953280, 3953281, 3953282, 3953284, 3953285, 3953286, 3953287, 3953288, 3953289, 3953290, 3953291, 3953293, 3953294, 3953295, 3953296, 3953297, 3953298, 3953299, 3953300, 3953301, 3953303, 3953304, 3953305, 3953306, 3953307, 3953308, 3953309, 3953310, 3953311, 4045079, 4045080, 4045081, 4045083, 4045084, 4045085, 4045086, 4045087, 4045089, 4045090, 4045091, 4045093, 4045094, 4045095, 4045096, 4045098, 4067199, 4067200, 4067201, 4067202, 4067203, 4067204, 4067205, 4067206, 4067207, 4067208, 4067209, 4067210, 4067211, 4067212, 4067213, 4067214, 4067215, 4067216, 4067217, 4067218, 4185365, 4185366, 4185367, 4185368, 4185369, 4185370, 4185371, 4185372, 4185373, 4205333, 4205334, 4205335, 4205336, 4205337, 4205338, 4205340, 4205341, 4205342, 4205343, 4205344, 4205345, 4205346, 4205347, 4205348, 4205349, 4205351, 4258724, 4258725, 4258727, 4258728, 4258729, 4258730, 4258731, 4258732, 4258733, 4258734, 4258736, 4258737, 4258738, 4258739, 4258740, 4258741, 4258742, 4258743, 4258744, 4258745, 4258746, 4258748, 4258749, 4258750, 4258751, 4258752, 4258753, 4258755, 4258756, 4258757, 4258758, 4258759, 4258761, 4258762, 4341781, 4341782, 4341785, 4341787, 4341788, 4341789, 4341790, 4341792, 4341793, 4341794, 4341796, 4341797, 4341798, 4341800, 4341801, 4341802, 4341803, 4341805, 4341806, 4341807, 4341808, 4341809, 4341810, 4341813, 4341814, 4341815, 4341816, 4341817, 4341833, 4341834, 4341835, 4341836, 4341837, 4341838, 4341839, 4341840, 4341841, 4341842, 4341843, 4341845, 4341846, 4341847, 4341848, 4341849, 4341850, 4341851, 4341852, 4350650, 4350651, 4350654, 4350655, 4350656, 4350658, 4350659, 4350660, 4350661, 4350662, 4350663, 4350664, 4350665, 4350666, 4350667, 4350668, 4350670, 4350671, 4350672, 4350674, 4350675, 4350676, 4350677, 4350678, 4350679, 4350680, 4350681, 4350682, 4350684, 4350685, 4350686, 4350689, 4483811, 4483813, 4483816, 4483820, 4483821, 4483822, 4483823, 4483825, 4483826, 4483827, 4483828, 4483829, 4483830, 4690175, 4690178, 4690181, 4690182, 4690183, 4690184, 4690185, 4690187, 4690189, 4690192, 4690193, 4690195, 4690197, 4690203, 4690204, 4690205, 4690206, 4690207, 4690208, 4690209, 4717550, 4717551, 4717552, 4717553, 4717554, 4717556, 4717557, 4717558, 4717559, 4717560, 4717562, 4717563, 4717564, 4717565, 4717566, 4717567, 4717568, 4717569, 4751409, 4751410, 4751412, 4751416, 4751417, 4751418, 4751424, 4807723, 4807724, 4807725, 4807726, 4807727, 4807728, 4807729, 4807731, 4807732, 4807733, 4807734, 4807735, 4807736, 4845024, 4845025, 4845030, 4845033, 4845034, 4845035, 4845037, 4845038, 4845039, 4845040, 4845042, 4845043, 4915886, 4915887, 4915888, 4915890, 4915892, 4915894, 4915895, 4915898, 4915899, 4915900, 4915901, 4915902, 4915906, 4915907, 4915908, 4915909, 4915911, 4915912, 4915913, 4915914, 4915915, 4915916, 4915917, 4915918, 4915919, 4915922, 4915923, 4915924, 6006875, 6006876, 6006879, 6006880, 6006882, 6006884, 6006885, 6006889, 6006891, 6066529, 6066532, 6066533, 6066534, 6066536, 6066537, 6066540, 6066541, 6066542, 6066544, 6075293, 6075294, 6075297, 6075298, 6075299, 6075304, 6075305, 6075308, 6075309, 6075312, 6082319, 6082321, 6082323, 6082324, 6082331, 6082332, 6082333, 6082334, 6082335, 6082336, 6442800, 6442804, 6442806, 6442808, 6442810, 6442811, S053852, S053853, S053854, S053857, S053858, S053861, S053863, S053864, S053869, S053871, S062922, S062930, S062947, S063093, S087265, S087271, S087274, S087284, S087285, S087286, S087288, S087298, S120399, S120408, S120410, S120413, S120415, S120435, Z079304); 02-012-35-1013 (10885862001702; 1398940, 1398941, 1398942, 1398943, 1398947, 1398949, 1398951, 1398954, 1398955, 1398956, 1398961, 1398965, 1452369, 1452372, 1452377, 1472472, 1472475, 1472477, 1472478, 1472481, 1472482, 1472484, 1472485, 1472486, 1472487, 1478833, 1478834, 1478836, 1478837, 1478840, 1480197, 1480198, 1480199, 1480200, 1480201, 1480202, 1480204, 1486085, 1486086, 1486088, 1486089, 1486093, 1486094, 1486098, 1486101, 1486102, 1486106, 1486108, 1486110, 1486113, 1712718, 1712721, 1712725, 1712726, 1712729, 1712730, 1712731, 1735727, 1735728, 1735730, 1735731, 1735733, 1735735, 1735737, 1735740, 1735741, 1735743, 1735746, 1767081, 1767083, 1767085, 1767088, 1767089, 1767091, 1767093, 1767094, 1767096, 1767101, 1767105, 1767107, 1825340, 1825342, 1825344, 1825348, 1853157, 1853158, 1853162, 1853163, 1853164, 1853166, 1853168, 1853169, 1853170, 1853171, 1853234, 1853235, 1853236, 1853237, 1853239, 1853241, 1891447, 1891448, 1891449, 1891450, 1891451, 1891455, 1891456, 1891458, 1891459, 1891460, 1891461, 1891463, 1891466, 1891467, 1891468, 1891469, 1891471, 1891473, 1891474, 1891476, 1906211, 1906213, 1906215, 1906216, 1906218, 1906219, 1906222, 1906225, 1906226, 1906229, 1906231, 1906232, 1906236, 1907813, 1907819, 1907821, 1907823, 1907824, 1907828, 1907829, 1907830, 1907835, 2024506, 2024509, 2024510, 2024513, 2024514, 2024515, 2047542, 2047543, 2047545, 2047546, 2047548, 2047550, 2047555, 2047556, 2047559, 2047560, 2047562, 2047563, 2047567, 2047569, 2047570, 2047571, 2143998, 2143999, 2144000, 2144001, 2144002, 2144004, 2144005, 2202711, 2202712, 2202714, 2202715, 2202716, 2282493, 2282495, 2282497, 2282498, 2282499, 2282500, 2282503, 2282506, 2282507, 2282508, 2282509, 2282510, 2369327, 2369330, 2369332, 2369335, 2369336, 2369338, 2369342, 2369344, 2403152, 2403153, 2403154, 2403159, 2403160, 2403161, 2403163, 2403164, 2403167, 2403171, 2422002, 2422003, 2422005, 2422006, 2422007, 2422009, 2422012, 2422013, 2422014, 2422015, 2422018, 2422020, 2422023, 2422026, 2422027, 2422029, 2422030, 2422031, 2422034, 2422035, 2422036, 2422039, 2422040, 2422041, 2491220, 2491221, 2491224, 2491226, 2491229, 2491231, 2491235, 2491236, 2533631, 2533634, 2533638, 2533639, 2533640, 2533641, 2533642, 2533645, 2533646, 2533648, 2533651, 2533653, 2533654, 2533655, 2533656, 2533657, 2533659, 2533660, 2533662, 2533663, 2533666, 2533667, 2533668, 2533669, 2753744, 2753745, 2753746, 2753747, 2753748, 2753750, 2753751, 2841041, 2841042, 2841043, 2841044, 2841045, 2841046, 2841048, 2841049, 2841050, 2841051, 2841052, 2841053, 2841054, 2841055, 2841056, 2841058, 2915707, 2915708, 2915709, 2915710, 2915711, 2915712, 2915713, 2915715, 2915716, 2970556, 2970557, 2970558, 2970559, 2970560, 2970561, 2970562, 2970563, 2970564, 2970565, 2970567, 2970568, 2970569, 2970570, 2970571, 2970572, 2970574, 3565020, 3565021, 3565022, 3565023, 3565024, 3565026, 3565027, 3565028, 3565029, 3565030, 3565032, 3565033, 3565034, 3565035, 3565036, 3565037, 3565038, 3565039, 3596926, 3596927, 3596928, 3596929, 3596930, 3596931, 3596932, 3596933, 3596934, 3596935, 3596936, 3596937, 3596938, 3596941, 3596942, 3596943, 3596944, 3628185, 3628186, 3628188, 3628189, 3628190, 3628191, 3628192, 3628193, 3628195, 3628196, 3628197, 3628198, 3628200, 3628201, 3628202, 3650511, 3650512, 3650513, 3650516, 3650517, 3650518, 3650521, 3650522, 3650523, 3650526, 3650528, 3650529, 3712713, 3712714, 3712715, 3712717, 3712718, 3712719, 3712720, 3712721, 3712722, 3712723, 3712724, 3712725, 3712726, 3712727, 3712728, 3712729, 3712730, 3712731, 3815999, 3816000, 3816001, 3816002, 3816003, 3816004, 3816005, 3816006, 3816007, 3816008, 3816009, 3816010, 3816011, 3816013, 3816016, 3816017, 3859818, 3859819, 3859820, 3859822, 3859823, 3859824, 3859826, 3859827, 3859828, 3859829, 3859830, 3859831, 3859832, 3859833, 3859834, 3859835, 3895594, 3895595, 3895596, 3895597, 3895598, 3895599, 3895600, 3895601, 3895602, 3895604, 3895605, 3895607, 3895609, 3895610, 3895611, 3895613, 3908769, 3908770, 3908771, 3908772, 3908774, 3908776, 3908777, 3908778, 3908779, 3908782, 3908786, 4093120, 4093121, 4093122, 4093123, 4093124, 4093125, 4093126, 4093127, 4093129, 4093131, 4093132, 4093133, 4093134, 4093136, 4093137, 4093139, 4157818, 4157819, 4157820, 4157821, 4157822, 4157823, 4157824, 4157827, 4157828, 4157830, 4157831, 4157832, 4157834, 4157835, 4196282, 4196283, 4196284, 4196285, 4196286, 4196287, 4196288, 4196289, 4196290, 4196291, 4196292, 4196293, 4196294, 4203438, 4203440, 4203441, 4203442, 4203445, 4203446, 4203447, 4203448, 4203449, 4203451, 4203452, 4203453, 4203454, 4203455, 4203456, 4341614, 4341615, 4341616, 4341618, 4341619, 4341620, 4341622, 4341623, 4341625, 4341626, 4341628, 4341629, 4341631, 4341632, 4341634, 4341637, 4341638, 4341644, 4341648, 4341650, 4448176, 4448177, 4448179, 4448180, 4448181, 4448182, 4448183, 4448185, 4448186, 4448188, 4448190, 4448191, 4448192, 4448193, 4448195, 4491437, 4491444, 4491445, 4491446, 4717573, 4717574, 4717575, 4717579, 4717580, 4717583, 4717584, 4717585, 4717587, 4717588, 4717589, 4769212, 4769213, 4769219, 4769220, 4769221, 4769223, 4769224, 4769226, 4769227, 4915736, 4915737, 4915738, 4915739, 4915742, 4915743, 4915745, 4915748, 4915750, 4915751, 4915754, 4915755, 4915756, 4915760, 4915763, 4915768, 4915769, 4915772, 4915773, 4915774, 5862401, 5862402, 5862403, 5862404, 5862408, 5862409, 5862415, 6060880, 6060884, S056594, S056596, S056600, S056603, S056604, S056605, S056607, S063158, S063163, S063173, S080151, S080161, S080163, S080166, S080179, S080182, Z078322, Z080762); 02-012-35-1015 (10885862001719; 1393907, 1393908, 1393909, 1393912, 1393914, 1396814, 1396818, 1396819, 1396820, 1440615, 1440616, 1440618, 1448795, 1448802, 1448803, 1448804, 1472267, 1472272, 1472274, 1478827, 1478828, 1478831, 1481812, 1481815, 1481816, 1481818, 1481819, 1481820, 1485411, 1485412, 1485413, 1485416, 1485418, 1485424, 1485428, 1485429, 1485434, 1735911, 1735913, 1735915, 1735917, 1735918, 1735919, 1735930, 1735936, 1735937, 1735939, 1735940, 1788355, 1788357, 1788362, 1788364, 1788369, 1788371, 1788372, 1788375, 1788377, 1788381, 1845730, 1845731, 1845736, 1845737, 1845739, 1853095, 1853189, 1853192, 1853197, 1853201, 1901233, 1901234, 1901237, 1901239, 1901240, 1901241, 1901242, 1901246, 1901248, 1906240, 1906248, 1907581, 1907586, 1907589, 1907597, 1907603, 1907605, 1907607, 2024114, 2024118, 2037512, 2037513, 2037518, 2037519, 2037520, 2037521, 2037525, 2037526, 2076974, 2076975, 2076979, 2076980, 2115870, 2115871, 2144034, 2144035, 2144036, 2144038, 2144039, 2144041, 2202925, 2202928, 2202929, 2202930, 2202931, 2202933, 2326007, 2326010, 2326012, 2326015, 2326019, 2326023, 2419507, 2419513, 2419519, 2419520, 2419526, 2419529, 2419540, 2419543, 2419545, 2419546, 2481063, 2481066, 2481067, 2481070, 2481071, 2481079, 2515856, 2515858, 2515859, 2515861, 2515862, 2515864, 2515865, 2515869, 2515871, 2573068, 2573070, 2573074, 2666896, 2666900, 2666902, 2666904, 2820429, 2820430, 2820432, 2820434, 2820435, 2820437, 2820439, 2820440, 2820441, 2820442, 2820443, 2820444, 2820446, 2932103, 2932104, 2932105, 2932106, 2932107, 2932108, 2932109, 2932111, 2932112, 2932113, 2932114, 2932115, 2932116, 2932117, 2932119, 2932120, 2932121, 2932122, 3597954, 3597955, 3597956, 3597957, 3597958, 3597959, 3597960, 3597963, 3597964, 3597965, 3597966, 3597967, 3597968, 3597969, 3597970, 3597971, 3597972, 3615064, 3615065, 3615066, 3615068, 3615072, 3615074, 3615075, 3615076, 3615077, 3615078, 3615080, 3615081, 3615082, 3819923, 3819924, 3819925, 3819926, 3819927, 3819928, 3819929, 3819930, 3819931, 3819932, 3819933, 3819934, 3819936, 3819937, 3884895, 3884896, 3884898, 3884903, 3884908, 3884909, 3884911, 3884914, 3970730, 3970731, 3970733, 3970734, 3970735, 3970740, 3970741, 3970742, 3970743, 3970744, 3970745, 4020233, 4020235, 4020237, 4020238, 4020239, 4020240, 4020241, 4020243, 4020244, 4020245, 4020246, 4020247, 4020250, 4190001, 4190003, 4190005, 4190018, 4415853, 4415855, 4415856, 4415859, 4415861, 4415863, 4415865, 4415871, 4483831, 4483839, 4483849, 4705873, 4705877, 4705880, 4705881, 4705882, 4705883, 4705885, 4705888, 4705891, 4769197, 4769199, 4769200, 4769202, 4769203, 4769204, 4769205, 4769209, 4769211, 4906820, 4906824, 4906828, 4906832, 4906833, 4906834, 4906837, 5838735, 5838744, 5838746, 5838747, 5838748, 5838750, S068227, S068230, S068237, S084160, S121663, S121665); 02-012-35-1017 (10885862247292; 2901030, 2901032, 2901040, 2901041, 2901043, 2910729, 2910732, 2910733, 2910736, 2910737, 2910742, 2910747, 2910755, 2910758, 2910760, 2910763, 2910764, 3784451, 3784452, 3815967, 3815968, 3815969, 3815971, 3815972, 3815974, 3815975, 3815976, 3864883, 3864884, 3864886, 3864889, 3864890, 3864891, 4079485, 4079487, 4079488, 4079489, 4079490, 4079491, 4170963, 4170970, 4170972, 4170973, 4170975, 4223232, 4426212); 02-012-35-1019 (10885862247308; 3741096, 3741099, 3814536, 3814537, 3814539, 3814540, 3814542, 3814543, 3814544, 3814545, 3814546, 3899833, 3899834, 3899840, 4008456, 4008459, 4008460, 4164659, 4164663, 4164664, 4164668, 4164672); 02-012-35-1509 (10885862180759; 2181957, 2181958, 2181960, 2181961, 2181962, 2181963, 2181965, 2181966, 2181967, 2181969, 2181972, 2181975, 2181976, 2207582, 2207583, 2207584, 2207585, 2207586, 2207587, 2207589, 2207591, 2207592, 2207594, 2207595, 2207596, 2207597, 2207599, 2207600, 2209066, 2209067, 2209069, 2209070, 2209071, 2209072, 2209073, 2209075, 2209077, 2209078, 2230311, 2230313, 2230314, 2230315, 2230317,

Distribution pattern

device · product 4 of 9

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 reflects Exactech recall expansion initiated on 02/07/2022.

Z-0022-2022

Recall number: Z-0022-2022
Initiated: August 30, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Exactech, Inc.
Quantity: 41 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Code information

a. Item Number (Device Identifier; Serial number(s)): 900-06-18 (10885862100375; 1667962, 1667963); 900-06-20 (10885862100382; 1667796, 1667797); 900-06-22(10885862100399; 1667744, 1667745); 900-08-18 (10885862100405; 1667794, 1667795); 900-08-20 (10885862100412; 1667929, 1667930); 900-08-22 (10885862100429; 1667879, 1667880); b. Item Number (Device Identifier; Serial number(s)): 900-23-02 (10885862100863; 0899804, 0899805, 0899806, 0899807); 900-23-03 (10885862100870; 0900400, 0900401, 0900402, 0900403); 900-23-04 (10885862100887; 0900408, 0900409, 0900410, 0900411, 0900412); 900-23-05 (10885862100894; 0900413, 0900414, 0900415, 0900416); 900-23-06 (10885862100900; 0900404, 0900405, 0900406, 0900407); 900-30-11 (10885862101068; 0565754, 0565755); 900-30-13 (10885862101075; 0565756, 0565757); c. Item Number (Device Identifier; Serial number(s)): 900-33-09 (10885862101082; 1822113, 1822114); 900-33-11 (10885862101099; 1822115, 1822116)

Distribution pattern

device · product 5 of 9

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: Information reflects Exactech recall expansion initiated on 02/07/2022.

Z-0023-2022

Recall number: Z-0023-2022
Initiated: August 30, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Exactech, Inc.
Quantity: 31,201 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Code information

a. Item Number (Device Identifier; Serial number(s)): 02-022-47-1009 (10885862306067; 4904358, 4904362, 4904363, 4904365, 5103012, 5132420, 5132432, 5186119, 5186125, 5186128, 5220427, 5220428); 02-022-47-1010 (10885862306074; 5054265, 5054269, 5054272, 5058395, 5058402, 5063328, 5063330, 5063335, 5063336, 5143808, 5143812); 02-022-47-1011 (10885862306081; 4715514, 4849121, 5101155, 5101164, 5108302, 5108315); 02-022-47-1012 (10885862306098, 5059598, 5059599, 5059601, 5073330, 5073334, 5073349, 5073352, 5073359, 5073378); 02-022-47-1013 (10885862306104; 4758320, 4758326, 4904379, 4904391, 5101413, 5153301, 5153309, 5153317, 5174543, 5174555); 02-022-47-1015 (10885862306128; 4904313, 4904317, 4904331, 5103330, 5124929, 5217018); 02-022-47-1509 (10885862306142; 5036961, 5036979, 5036982, 5058640, 5058655, 5058656, 5058657, 5101225, 5101226, 5101229, 5101231, 5101232, 5101238, 5168416, 5168417, 5168422, S235767); 02-022-47-1510 (10885862306159; 5085658, 5085662, 5085668, 5085681, 5085682, 5085705, 5085707, 5085718, 5085721, 5085722, 5085728, 5148139, 5148140, 5148147, 5230312, 5230322, 5390682); 02-022-47-1511 (10885862306166; 4998108, 4998112, 4998120, 4998128, 4998131, 4998133, 4998138, 5010573, 5010577, 5010578, 5063133, 5152788, 5152794, 5254482); 02-022-47-1512 (10885862306173; 5057888, 5057891, 5057895, 5057897, 5057926, 5128943, 5128946, 5174523, 5174535, 5174541, 5373484, 5373486); 02-022-47-1513 (10885862306180; 5036901, 5036902, 5036906, 5036935, 5091477, 5155207, 5254434); 02-022-47-1515 (10885862306258; 5035052, 5035055, 5035056, 5148160); 02-022-47-1517 (10885862306265; 5174515); 02-022-47-2009 (10885862306272; 4751940, 4751944, 4751946, 4751947, 4751949, 4751950, 4773516, 4773517, 4773518, 4773521, 4773522, 4773523, 4773526, 4773527, 4920753, 4920754, 4920755, 4920756, 4920758, 4920759, 4920762, 5069996, 5069998, 5069999, 5070000, 5070001, 5070002, 5070003, 5070005, 5070006, 5070007, 5070012, 5070017, 5070019, 5119730, 5119733, 5119734, 5119735, 5119737, 5119739, 5119740, 5119743, 5119746, 5119749, 5221997, 5222000, 5222001, 5222004, 5222005, 5222007, 5222009, 5222012, 5222013, 5222016, 5222017, 5222018, 5222022, 5222024, 5222026, 5222029, 5222030, 5222031, 5222033, 5222034, 5222036, 6943269, S044753, S044758, S044761, S044762, S044763, S044764, S044767, S044768, S064697, S064698, S064699, S078054, S078056, S078057, S078062, S078063, S078066, S078067, S078069, S078072, S078073, S078078, S078080, S078081, S078082, S078087, S078097, S078101, S078104, S078107, S246601, S246616, Z056123, Z056124, Z063902, Z063903, Z069601, Z069603); 02-022-47-2010 (10885862311344; 5054239, 5054242, 5054244, 5054245, 5054247, 5056080, 5056082, 5056085, 5056086, 5056087, 5056089, 5056092, 5056093, 5056094, 5056098, 5056101, 5056102, 5056103, 5066380, 5066381, 5066385, 5066396, 5066397, 5066398, 5119885, 5119889, 5119890, 5119894, 5217323, 5217324, 5217325, 5217326, 5217327, 5217329, 5217332, 5217334, S084971, S234331); 02-022-47-2011 (10885862306289; 4684423, 4684424, 4684425, 4684426, 4684428, 4684429, 4718053, 4718056, 4718060, 4718061, 4773399, 4773400, 4773403, 4920741, 4920745, 4920746, 4920750, 4920751, 5101186, 5101192, 5101194, 5101197, 5101199, 5101202, 5130146, 5130147, 5130150, 5130154, 5130162, 5130163, 5130165, 5130168, 5130169, 5130172, 5130176, 5220466, 5220468, 5220470, 5220475, 5220477, 5220479, 5220488, 5220495, S092853, Z053639); 02-022-47-2012 (10885862311429; 5053846, 5053852, 5053853, 5053858, 5053859, 5053861, 5053864, 5053869, 5053871, 5053879, 5053883, 5053884, 5070103, 5070106, 5070107, 5070108, 5070114, 5070123, 5070129, 5070132, 5070134); 02-022-47-2013 (10885862306296; 4684432, 4684435, 4684437, 4684438, 4684441, 4684443, 4753038, 4753048, 4900078, 4900079, 4900083, 4900090, 4900093, 5103469, 5103470, 5103475, 5103476, 5103480, 5103483, 5103485, 5119804, 5119806, 5119808, 5119812, 5119815, 5119819, 5119820, 5119825, 5119832, 5219855, 5219858, 5219859, 5219862, 5219867, 5219869, S221489); 02-022-47-2015 (10885862306302; 4684444, 4684446, 4684447, 4684449, 4684453, 4765784, 4899827, 4899830, 4899833, 4899834, 5064301, 5064304, 5064305, 5064308, 5064314, 5064317, 5129010, 5129019, 5129021, 5129024, 5129028, 5129030, 5220184, 5220189, S203101); 02-022-47-2017 (10885862306319; 5065369, 5065407); 02-022-47-2509 (10885862306326; 4684399, 4684400, 4684401, 4684403, 4684404, 4765817, 4765819, 4765820, 4765822, 4765823, 4765825, 4765826, 4900035, 4900036, 4900037, 4900038, 4900042, 4900043, 4900044, 4900045, 4916904, 4916905, 4916907, 4916908, 4916909, 4916910, 4916911, 4916912, 4916913, 4916914, 4916915, 5042988, 5042991, 5042992, 5042993, 5042995, 5042996, 5042998, 5043000, 5043002, 5043003, 5043007, 5043010, 5043012, 5063223, 5063225, 5063226, 5063229, 5063231, 5063232, 5063233, 5063234, 5209024, 5209026, 5209029, 5209030, 5209036, 5209040, 5209043, 5209045, 5209047, 5209053, 5209054, 5209055, 5209056, 5209058, 5209061, 5209062, 5209063, 5209068, S050046, S050057, S050058, S050059, S077842, S077847, S077854, S077855, S077856, S077867); 02-022-47-2510 (10885862311351; 5054687, 5054688, 5054691, 5054692, 5054693, 5054694, 5054695, 5054696, 5054698, 5054699, 5054702, 5054709, 5054710, 5054713, 5054716, 5054718, 5054724, 5054729, 5054730, 5054732, 5054735, 5054738, 5054740, 5054741, 5054742, 5054745, 5054748, 5054749, 5054750, 5054754, 5054762, 5054763, 5054764, 5054766, 5054768, 5054770, 5054772, 5054773, 5054774, 5054775, 5228152, 5228156, 5228157, 5228161, 5228164, S085427); 02-022-47-2511 (10885862306333; 4760673, 4760674, 4760675, 4760681, 4760684, 4899700, 4899702, 4899705, 4899709, 4899712, 4899713, 4899716, 4899720, 4899721, 4899722, 5065217, 5065218, 5065222, 5065223, 5065225, 5065229, 5065230, 5065232, 5065235, 5095042, 5095047, 5095048, 5095049, 5095051, 5095054, 5168403, 5168406, 5168409, 5168410, 5220501, 5220512, S122376, Z055885); 02-022-47-2512 (10885862311436; 5055145, 5055147, 5055152, 5055158, 5055159, 5055162, 5055165, 5055166, 5055171, 5055173, 5055176, 5055184, 5055195, 5055197, 5055199, 5055201, 5055204, 5055208, 5070443, 5095230, 5219872, 5219874, 5219880); 02-022-47-2513 (; 4764989, 4764990, 4764991, 4764993, 4764995, 4764997, 4899797, 4899798, 4899801, 4899813, 4899815, 5092625, 5092628, 5092635, 5092650, 5092657, 5092658, 5168992, 5169002, 5169006, 5169016, 5169022, Z055962); 02-022-47-2515 (10885862306357; 4753030, 4753032, 4753036, 4899985, 5094316, 5094323, 5094325, 5094350, 5094353, 5220069, 5220081); 02-022-47-2517 (10885862306364; 5108067, 5136880); 02-022-47-3009 (10885862306371; 4726122, 4726123, 4726128, 4726131, 4726132, 4726133, 4744267, 4744271, 4744272, 4744274, 4744276, 4773359, 4773360, 4773361, 4773362, 4773363, 4773364, 4773365, 4773368, 4773369, 4773370, 4929478, 4929480, 4929481, 4929482, 4929484, 4929487, 4929489, 4929498, 4929499, 4929501, 4933581, 4933582, 4933583, 4933585, 4933587, 4933589, 5042636, 5042637, 5042638, 5042640, 5042642, 5042644, 5042645, 5042646, 5042647, 5042648, 5042649, 5042651, 5042652, 5042653, 5042654, 5042658, 5116916, 5116917, 5116918, 5116920, 5116921, 5116922, 5116923, 5116924, 5116925, 5116926, 5116927, 5116928, 5116929, 5116930, 5116932, 5116933, 5116934, 5116935, 5116936, 5116937, 5116938, 5228507, 5228509, 5228510, 5228511, 5228512, 5228513, 5228514, 5228517, 5228518, 5228519, 5228520, 5228521, 5228523, 5228525, 5228528, 5228529, 5228530, 5228531, 5228534, 5228536, 5228537, 5228539, 5228543, 5228544, 5228545, 5228549, 5228550, 6943911, 6943915, S038177, S038178, S038179, S038180, S038181, S038182, S038183, S038184, S038185, S038187, S038188, S038190, S038191, S038192, S038193, S038194, S038195, S045557, S045558, S045559, S045560, S045561, S045562, S045563, S045564, S045567, S045569, S045570, S045571, S045572, S045573, S045575, S053122, S053123, S053126, S053128, S053130, S053131, S058214, S058215, S058216, S058217, S058219, S058221, S058222, S058225, S058226, S058227, S058231, S064732, S064733, S064734, S064735, S064736, S064737, S064738, S064740, S064741, S064742, S064743, S064745, S064746, S064748, S064749, S064751, S077336, S077339, S077340, S077341, S077344, S077345, S077347, S077348, S077355, S077356, S077357, S077358, S077359, S077360, S077365, S077367, S077368, S077371, S077372, S077373, S077375, S077376, S077377, S077378, S077380, S077382, S077384, S077388, S077389, S077394, S077395, S077399, S077400, S077402, S077403, S077404, S077405, S077407, S077408, S077409, S077411, S215347, S215354, S250290, S250298, S250302, S250325, S250326, S250328, Z052263, Z052267, Z052269, Z052270, Z052275, Z052276, Z054212, Z054214, Z054216, Z054217, Z054218, Z054220, Z074561); 02-022-47-3010 (10885862311368; 5055215, 5055216, 5055221, 5055224, 5055226, 5055227, 5055230, 5055231, 5055236, 5055240, 5055241, 5055242, 5055246, 5055248, 5055252, 5055253, 5055255, 5055257, 5055259, 5067757, 5067758, 5067759, 5067760, 5067762, 5067765, 5067767, 5101240, 5101241, 5101242, 5101243, 5101244, 5101247, 5101248, 5101249, 5101250, 5101252, 5101255, 5101256, 5101257, 5148128, 5148129, 5148130, 5148134, 5228033, 5228034, 5228035, 5228038, 5228039, 5228042, 5228043, 5228044, 5228046, 5228047, 5228048, 5228051, 5228053, S079073, S079075, S079076, S079081, S079099, S079101, S079110, S079112, Z064021, Z066150); 02-022-47-3011 (10885862306388; 4726170, 4726171, 4726172, 4726173, 4726174, 4726176, 4726179, 4726180, 4737852, 4737854, 4737855, 4737856, 4737857, 4737859, 4737860, 4737862, 4850847, 4850850, 4850852, 4850857, 4850858, 4904813, 4904814, 4904819, 4904820, 4904822, 5047342, 5047343, 5047344, 5047345, 5047350, 5047351, 5047353, 5047355, 5047357, 5047360, 5047362, 5047363, 5047366, 5059661, 5059662, 5059663, 5059664, 5059665, 5059668, 5059671, 5228551, 5228553, 5228554, 5228555, 5228556, 5228558, 5228563, 5228565, 5228568, 5228569, 5228570, 5228572, 5228573, 5228579, 5228580, 5228581, 5228584, 5228585, 5228588, 5228589, 5228590, 5228593, 5228595, 5228596, 5228597, 5228598, S064970, S064974, S064976, S064981, S077688, S077689, S077693, S077694, S077699, S077711, S077712, S077714, S221061, Z053428, Z053429, Z069567); 02-022-47-3012 (10885862311443; 5054118, 5054124, 5054128, 5057851, 5057855, 5057859, 5057860, 5057865, 5057866, 5057869, 5067138, 5067141, 5067142, 5067147, 5067152, 5067156, 5116889, 5116894, 5228019, 5228021); 02-022-47-3013 (10885862306395; 4737919, 4737920, 4737921, 4737922, 4737923, 4737924, 4737927, 4737929, 4737930, 4744217, 4744220, 4744222, 4744224, 4744227, 4744228, 4901572, 4901577, 4901589, 4901590, 4901594, 4901595, 5065140, 5065145, 5065155, 5065157, 5065162, 5065163, 5065165, 5065167, 5065170, 5065175, 5117017, 5117018, 5117019, 5117021, 5117022, 5117024, 5117030, 5229175, 5229177, 5229178, 5229179, 5229181, 5229182, 5229185, 5229186, 5229187, 5229189, 5229190, 5229191, 5229192, 5229193, 5229194, 5229196, 5229198, 5229200, 5229201, 5229204, S203756, S203767, S203770, X7098542); 02-022-47-3015 (10885862306401; 4723532, 4723533, 4723534, 4723535, 4723536, 4723537, 4723540, 4723541, 4760334, 4901622, 4901623, 4901630, 4901640, 4901643, 5075846, 5075855, 5075861, 5116876, 5116880, 5116881, 5116884, 5116886, 5168725, 5168726, 5168732, 5168733, 5168749, 5168750, 5230788, 5230790, 5230798, S028322, S028332); 02-022-47-3509 (10885862306425; 4684457, 4684459, 4684462, 4684463, 4684464, 4684465, 4684466, 4760686, 4760689, 4760690, 4760692, 4760693, 4760694, 4760695, 4760696, 4901525, 4901526, 4901527, 4901532, 4901533, 4901534, 4901535, 4901536, 4901537, 4901540, 4901541, 4901542, 4901543, 4901546, 4901547, 4901548, 5064275, 5064276, 5064277, 5064278, 5064279, 5064282, 5064283, 5064284, 5064289, 5064290, 5100520, 5100522, 5100523, 5100524, 5100525, 5100529, 5100530, 5100532, 5100536, 5100537, 5100538, 5100539, 5100540, 5100541, 5100542, 5100544, 5100545, 5100546, 5100547, 5100548, 5100549, 5100550, 5100551, 5100552, 5100553, 5100554, 5230548, 5230549, 5230550, 5230551, 5230552, 5230554, 5230555, 5230556, 5230557, 5230558, 5230560, 5230561, 5230562, 5230563, 5230566, 5230567, 5230568, 5230569, 5230570, 5230571, 5230572, 5230575, 5230576, 5362916, 5362918, 5362919, 5362921, 5362922, 5362925, 5362926, 5362927, 5362928, 5362929, 5362930, 5362932, 5362933, 5362935, 5362936, 5362937, 5362940, 5362941, 5362942, 5362943, 5362944, 5362945, 5362946, 5362947, 5516373, 5516375, 5516376, 5516377, 5516378, 5516379, 5516380, 5516381, 5516383, 5516384, 5516386, 5516387, 5516390, 6935863, M005456, M005459, M005463, M005464, M005466, M005467, S021702, S021704, S021705, S021706, S021708, S021709, S021711, S021717, S030510, S030511, S030513, S030514, S030518, S030521, S030528, S063398, S063400, S063403, S063404, S063407, S063408, S063409, S063411, S063412, S063414, S063417, S063419, S063420, S063423, S063424, S078278, S078280, S078286, S078289, S078296, S078298, S078299, S078300, S078301, Z050323, Z055034, Z055035, Z055036, Z069635, Z071659, Z071676, Z071683, Z075928); 02-022-47-3510 (10885862311375; 5058486, 5058488, 5058490, 5058493, 5058495, 5058496, 5058498, 5058499, 5058506, 5058509, 5058590, 5058603, 5058604, 5058606, 5058608, 5058610, 5058611, 5058615, 5061661, 5061664, 5061669, 5061670, 5081944, 5081948, 5081951, 5081952, 5081954, 5081957, 5081959, 5081962, 5230863, 5230864, 5230866, 5230869, 5230871, 5230872, 5230873, 5230874, 5362837, 5362838, 5362839, 5362840, 5362841, 5362844, 5362845, 5362847, 5362848, 5362858, 5362861, 5362865, 5362868, 5362877, 5362883, 5516056, 5516057, 5516060, 5516062, 5516066, 5516072, 5582437, 5582443, S085350, S085351, S085352, S085353, S085358, S085360, S085361, Z060222); 02-022-47-3511 (10885862306432; 4703890, 4703894, 4703895, 4703896, 4703897, 4703898, 4703901, 4760210, 4760211, 4760212, 4760216, 4760217, 4760218, 4760219, 4901604, 4901605, 4901608, 4901615, 4901617, 5086314, 5086316, 5086317, 5086319, 5086327, 5086330, 5100679, 5100680, 5100685, 5100689, 5100690, 5100691, 5100692, 5100693, 5100695, 5156799, 5230919, 5230920, 5230923, 5230925, 5230926, 5230927, 5230928, 5230933, 5230936, 5230937, 5230939, 5230942, 5230944, 5230946, 5230948, 5230949, 5230950, 5230951, 5361549, 5361550, 5361551, 5361553, 5361556, 5361558, 5361560, 5361578, 5432195, 5432206, 5432207, 5432212, 5432213, 5516430, S112446, S215448, Z054827); 02-022-47-3512 (10885862311450; 5053892, 5053893, 5053896, 5057803, 5057805, 5057823, 5057824, 5075243, 5075244, 5075246, 5075248, 5075249, 5075252, 5075254, 5075256, 5075257, 5100449, 5100455, 5100456, 5232914, 5232915, 5232918, 5292766, 5362828, M003150, M003157, Z071846); 02-022-47-3513 (10885862306449; 4696449, 4696453, 4764977, 4764978, 4764980, 4764983, 4764984, 4764986, 4901650, 4901653, 4901654, 4901657, 4901660, 4901665, 4901666, 5106624, 5132119, 5132122, 5132124, 5144313, 5228686, 5228687, 5228692, 5228705, 5228715, 5360196, 5360199, 5360210, 5518357, 5518368, 5518376, 5518382, 5518385, 5518387, X7099684); 02-022-47-3515 (10885862306456; 4670501, 4670505, 4765831, 4765833, 4765836, 4902235, 4902244, 4902245, 5077178, 5094723, 5094730, 5094732, 5226528, 5518432); 02-022-47-3517 (10885862306463; 5106735); 02-022-47-4009 (10885862306470; 4696431, 4696433, 4696435, 4696437, 4696439, 4696440, 4696441, 4753076, 4753078, 4753079, 4753083, 4753084, 4753085, 4859286, 4859287, 4859288, 4859289, 4859290, 4859292, 4859293, 4859294, 4859295, 4859296, 4905376, 4905377, 4905378, 4905380, 4905383, 4905385, 4905386, 4905387, 4905388, 4905389, 4905390, 4905391, 4905393, 4905394, 5098336, 5098337, 5098338, 5098339, 5098340, 5098341, 5098344, 5098346, 5098347, 5098348, 5098350, 5098351, 5098352, 5098355, 5098357, 5098358, 5135729, 5135730, 5135731, 5135734, 5135735, 5135738, 5135739, 5135740, 5211332, 5211333, 5211334, 5211335, 5211336, 5211338, 5211339, 5211341, 5211342, 5211343, 5211344, 5211346, 5211348, 5211349, 5211350, 5211351, 5211352, 5211353, 5211355, 5211357, 5211358, 5211359, 5211360, 5211361, 5211362, 5211363, 5211364, 5211365, 5211366, 5211367, 5211368, 5211369, 5211370, 5211372, 5211373, 5383555, 5383556, 5383557, 5383558, 5383559, 5383560, 5383561, 5383562, 5383563, 5383564, 5383565, 5383566, 5383567, 5383568, 5383569, 5383570, 5383573, 5383575, 5383576, 5383577, 5383579, 5383580, 5383581, 5517487, 5517488, 5517491, 5517493, 5517494, 5517495, 5517496, 5517497, 5517498, 5517499, 5517501, 5517504, 5517505, 6999331, M004378, M004381, M004383, M004384, M004385, M004387, M004388, M004389, M004390, M004392, M004395, S023964, S023968, S023969, S023970, S023971, S023976, S023977, S023978, S023979, S023980, S039279, S039281, S039282, S039283, S039284, S039285, S039286, S039287, S039288, S039289, S039290, S039291, S039293, S039294, S039295, S039297, S045774, S045776, S045777, S045779, S045782, S045783, S045784, S045785, S045786, S045787, S045788, S045789, S052600, S052601, S052603, S052607, S052608, S052610, S052611, S052613, S052616, S052618, S052619, S062220, S062221, S062222, S062224, S062225, S062226, S062230, S062232, S062233, S062235, S062237, S062244, S062245, S062246, S062248, S077980, S077981, S077982, S077984, S077985, S077986, S077995, S077996, S077997, S077998, S078001, S078002, S078005, S078006, S078007, S078008, S078014, S078020, S078021, S078023, S078027, S078028, S078030, S078031, S078032, S078035, S078037, S078038, S078039, S078041, S078047, S078049, S078050, S078051, S078052, S078053, S206335, S206337, S206338, S206339, S206340, S206341, S206343, S206345, S206347, S206348, S206349, S206353, S206354, Z052579, Z052589, Z053002, Z053009, Z053016, Z053021, Z053022, Z053023, Z058469, Z069683, Z069684); 02-022-47-4010 (10885862311382; 5054946, 5054947, 5054949, 5054951, 5054952, 5054953, 5054954, 5054955, 5054958, 5054959, 5054962, 5054965, 5054970, 5054971, 5054972, 5054973, 5055000, 5055001, 5055002, 5055003, 5055006, 5055008, 5055009, 5055013, 5055015, 5102056, 5102057, 5102058, 5102061, 5114030, 5114031, 5114033, 5114035, 5114037, 5114038, 5114039, 5114041, 5114043, 5114046, 5143790, 5143794, 5143797, 5143798, 5143799, 5143801, 5230579, 5230582, 5230583, 5230587, 5230593, 5230594, 5373150, 5373151, 5373156, 5373165, 5373168, 5373171, 5373174, 5373177, 5373182, 5373183, 5373186, 5388717, 5388718, 5518575, 5518581, 5518582, 5518592, M009273, M009280, S122501, S122503, S122512, S122513, Z053814, Z058548); 02-022-47-4011 (10885862306487; 4703836, 4703837, 4703838, 4703840, 4703845, 4703846, 4703847, 4768587, 4768588, 4768589, 4768591, 4768593, 4768594, 4768595, 4768596, 4901550, 4901554, 4901555, 4901558, 4901559, 4901560, 4901561, 4901562, 4901564, 4901566, 4901567, 4901569, 4901571, 5065531, 5065532, 5065533, 5065534, 5065535, 5065537, 5065539, 5065540, 5065546, 5065547, 5065550, 5095252, 5095253, 5095257, 5095258, 5095259, 5095261, 5095262, 5117185, 5117186, 5117187, 5117189, 5117190, 5117191, 5117193, 5117195, 5117198, 5117199, 5117200, 5117202, 5226594, 5226597, 5226598, 5226600, 5226601, 5226604, 5226608, 5226612, 5226613, 5226615, 5226617, 5226618, 5226621, 5226622, 5226623, 5226624, 5226626, 5226628, 5362966, 5362968, 5362970, 5362971, 5362972, 5362974, 5362975, 5362977, 5362978, 5362979, 5362981, 5362985, 5362987, 5362993, 5362995, 5362996, 5362997, 5362999, 5363003, 5363004, 5425845, 5425846, 5425848, 5425849, 5425850, 5425857, 5425860, 5425861, 5516833, 5516834, 5516836, 5516839, 5516840, 5516845, 5516850, M005717, M005718, M005723, M005726, M005731, M005732, M007911, M007912, M007916, M007919, M007920, M007921, M007922, M007925, S092530, S092538, S092539, S092544, S092547, S206848, S206849, Z054700, Z054709, Z055741, Z058683); 02-022-47-4012 (10885862311467; 5056132, 5056133, 5056134, 5056136, 5056137, 5056143, 5056147, 5056151, 5056153, 5056156, 5056594, 5056596, 5056598, 5056599, 5056600, 5056607, 5101434, 5101435, 5101437, 5101444, 5101446, 5144800, 5144805, 5144808, 5144812, 5144814, 5232907, 5232912, 5232913, 5361601, 5361606, 5361607, 5361613, 5361616, 5385558, 5385567, M005759, S221491); 02-022-47-4013 (10885862306494; 4704015, 4704017, 4704020, 4704021, 4704022, 4704026, 4777859, 4777861, 4777862, 4777864, 4777866, 4777868, 4777869, 4901960, 4901964, 4901966, 4901969, 4901970, 4901976, 4901978, 4901981, 5086333, 5086334, 5086336, 5086347, 5086349, 5116391, 5116394, 5116398, 5116400, 5116402, 5116403, 5116407, 5116409, 5116417, 5116418, 5116420, 5233681, 5233683, 5233685, 5233698, 5384426, 5384431, 5384435, 5384450, 5406640, 5437325, 5437326, 5437327, 5516412, 5516413, 5516414, 5516422, 5516426, 5516427, 5516429, M007848, M007850, M007858); 02-022-47-4015 (10885862306500; 4622146, 4622147, 4622148, 4622149, 4622151, 4622153, 4711837, 4711842, 4711844, 4711845, 4901831, 4901833, 5076900, 5076902, 5076912, 5076915, 5076916, 5085887, 5144737, 5144738, 5144745, 5144752, 5144753, 5226457, 5226461, 5226466, 5226475, 5226479, 5226488, 5383526); 02-022-47-4017 (10885862306517; 5036545); 02-022-47-4509 (10885862306524; 5008494, 5008495, 5008496, 5008498, 5008503, 5008504, 5008506, 5008509, 5008511, 5026168, 5026170, 5026171, 5026172, 5026174, 5026177, 5026179, 5026180, 5026181, 5026182, 5026186, 5026187, 5026189, 5026193, 5122927, 5136890, 5136891, 5177672, 5177674, 5177675, 5177676, 5215346, 5215347, 5215348, 5215350, 5215351, 5215353, 5215355, 5215356, 5215358, 5215360, 5215361, 5215364, 5267533, 5267535, 5267536, 5267540, 5277051, 5277054, 5277055, 5385572, 5385573, 5385575, 5385581, 5385588, 5385590, 5385591, 5385592, 5385594, 5385595, 5385598, 5385600, 5385605, 5385607, 5395818, 5395822, 5395824, 5395832, 5395833, 5516454, 5516455, 5516458, 5516459, M004602, M004603, M004605, M004607, M004609, M004613, M004614, M004615, M004617, S079001, S079006, S079007, S079011, S079012, S079021, S079023, S079026, S079027, S079030, S079031, S079032, S261974, S261990, Z057172, Z057175, Z057177, Z057179, Z061546, Z065239); 02-022-47-4510 (10885862311399; 5056206, 5056211, 5085896, 5085897, 5085909, 5085911, 5085913, 5085915, 5085916, 5085920, 5152700, 5152703, 5152705, 5152706, 5236431, 5236434, 5261059, 5261068, 5307839, 5373113, 5373117, 5373119, 5373130, 5373146, 5398833, 5398834, 5516464, 5516474, 5516478, 5581230, 5581235, 5581239, Z063306); 02-022-47-4511 (10885862306531; 5037277, 5037282, 5037283, 5037285, 5037302, 5037308, 5073992, 5073994, 5073995, 5073996, 5073997, 5136591, 5172619, 5172620, 5172622, 5172624, 5172627, 5172628, 5230602, 5230604, 5285848, 5303410, 5303425, 5386124, 5386131, 5386132, 5386137, 5386138, 5386140, 5386141, 5386142, 5390657, 5390665, 5517002); 02-022-47-4512 (10885862311474; 5054208, 5085931, 5085932, 5147165, 5156689, 5254426, 5315285, 5315288, 5389640, 5389645, 5518566, M005363); 02-022-47-4513 (10885862306548; 5037314, 5042939, 5042954, 5074379, 5074381, 5074384, 5074389, 5173313, 5173315, 5173320, , 5235996, 5408391, 5581752, Z057241); 02-022-47-4515 (10885862306555; 5009361, 5009368, 5123182, 5202199, 5202208, 5202212, 5385673); 02-022-47-4517 (10885862306562; 5162657, 5177733, 5268607, 5347889); 02-022-47-5009 (10885862306579; 4677067, 4677068, 4677069, 4690765, 4690766, 4690767, 4690768, 4744208, 4744209, 4744210, 4744211, 4744212, 4744213, 4744214, 4744215, 4744216, 4901890, 4901893, 4901895, 4901896, 4901897, 4901898, 4901899, 4901901, 4939811, 4939812, 4939813, 4939816, 4939817, 4939818, 4939819, 4939820, 4939821, 5064805, 5064806, 5064809, 5064811, 5064815, 5064816, 5064817, 5064819, 5064821, 5108318, 5108319, 5108320, 5108321, 5108322, 5108323, 5108327, 5108328, 5108330, 5108331, 5108332, 5108334, 5229261, 5229262, 5229263, 5229266, 5229267, 5229269, 5229271, 5229274, 5229278, 5229281, 5229282, 5229283, 5229285, 5229287, 5229288, 5229289, 5229290, 5229291, 5229294, 5229295, 5229299, 5229300, 5229301, 5229302, 5375468, 5375469, 5375470, 5375472, 5375475, 5375478, 5375479, 5375480, 5375482, 5375483, 5375484, 5395998, 5396002, 5396003, 5396004, 5516630, 5516631, 5516632, 5516633, 5516634, 5516635, 5516637, 5516640, 5516642, M004163, M004166, M004168, M004169, M004170, M004171, M004172, M004173, M004174, M004176, M004179, M004180, M004181, M004182, M009849, M009850, M009851, M009853, M009855, S050657, S050660, S050661, S050663, S050665, S050670, S050671, S050672, S050674, S078117, S078136, S078144, S078147, S078150, S078151, S078159, S078162, S078163, S078164, S122519, S122520, S122522, S122524, S122531, Z057270, Z060999, Z061002, Z061005); 02-022-47-5010 (10885862311405; 5055293, 5055294, 5055295, 5055299, 5055306, 5055307, 5055308, 5055310, 5055322, 5055323, 5055327, 5055328, 5055332, 5055335, 5055336, 5055337, 5055338, 5055341, 5055346, 5055347, 5055348, 5101531, 5101533, 5101535, 5101540, 5101541, 5109892, 5231026, 5231029, 5231034, 5231037, 5231038, 5377764, 5377770, 5377796, 5430316, 5517508, 5517511, M006612, S089009, S223025, S223027, Z058026); 02-022-47-5011 (10885862306586; 4670369, 4670373, 4670376, 4753051, 4753054, 4753058, 4753061, 4900048, 4900049, 4900050, 4900052, 4900061, 4900062, 4900064, 4900065, 5068304, 5068305, 5068310, 5068312, 5068313, 5068314, 5068315, 5101476, 5101485, 5101486, 5101487, 5101488, 5132058, 5132060, 5132061, 5132063, 5132065, 5135743, 5135746, 5135747, 5135749, 5220131, 5220139, 5220140, 5220148, 5220160, 5220164, 5220166, 5220167, 5372721, 5372729, 5372738, 5372740, 5372741, 5516950, 5516952, 5516956, 5516963, 5516965, M009758, Z057223); 02-022-47-5012 (10885862311481; 5055265, 5055268, 5055269, 5055272, 5055276, 5055278, 5055280, 5055288, 5055290, 5059784, 5059792, 5059795, 5059801, 5059803, 5068318, 5103492, 5378756, M003628); 02-022-47-5013 (10885862306593; 4703716, 4703717, 4703721, 4703722, 4703723, 4703724, 4760698, 4760699, 4760701, 4901504, 4901515, 4901517, 5067096, 5067099, 5067106, 5067107, 5067108, 5067113, 5132379, 5132382, 5132386, 5168813, 5168822, 5226658, 5226678, 5362544, 5362550, 5516486, 5516487, 5582421, 5582430, Z057892); 02-022-47-5015 (10885862306609; 4703777, 4757660, 4757664, 4757665, 4757669, 4901871, 4901879, 5067128, 5132052, 5132054, 5199768, 5199770, 5199774, 5199780, 5199782, 5378615, 5378617, M010186, S022918, Z059175); 02-022-47-6009 (10885862306623; 5095297, 5095298, 5095300, 5095303, 5095304, 5095307, 5095308, 5095309, 5095313, 5095314, 5236409, 5236410, 5236418, 5236419, 5236425, 5278579, 5278582, 5278588, 5278592, 5278593, 5278594, 5390006, 5524847, 5524849, 5524850, 5847347, 5964473, 5964475, S027533, S027534, S027536, S027540, S100004, Z058833); 02-022-47-6010 (10885862311412; 5489427, 5489438, 5489448, 5489465, 5489466, 5988081, 5988083, 5988087, S034953, Z061574, Z074744); 02-022-47-6011 (10885862306630; 5036439, 5036440, 5038982, 5038984, 5038985, 5236401, 5465672, 5621928, 5621930, 5986766, 5986769, 5986771, S026097, S026100, S026112); 02-022-47-6012 (10885862311498; 5504178, 5628047); 02-022-47-6013 (10885862306647; 5091469, 5103062, 5236535, 5446194); 02-022-47-6015 (10885862306654; 5103021, 5294322, 5479007); 02-022-47-6017 (10885862306661; 5435587); b. Item Number (Device Identifier; Serial number(s)): 02-022-48-1009 (10885862306708; 4723855, 4907359, 5063581, 5063589, 5227118); 02-022-48-1011 (10885862306715; 4772734, 4848972, 4848975, 5233710, 5233712); 02-022-48-1013 (10885862306722; 4696463, 4907348, 4907349, 5261083); 02-022-48-1509 (10885862306739; 5009378, 5009386, 5009398, 5009399, 5018667, 5018671, 5018676, 5227203); 02-022-48-1511 (10885862306746; 5036065, 5036074, 5036080, 5036096, 5254509); 02-022-48-1513 (10885862306753; 5058543, 5058551, 5058556, 5058567, 5058574, 5106672, 5261097, 5261102); 02-022-48-2009 (10885862306760; 4753273, 4753275, 4753278, 4773352, 4773354, 4773355, 4773357, 4920630, 4920632, 4920633, 4920634, 4920635, 4920638, 5103251, 5103259, 5103260, 5132492, 5132494, 5168829, 5222076, 5222082, 5222085, 5222096, 5222099, 5222101); 02-022-48-2011 (10885862306777; 4728958, 4728961, 4728962, 4728965, 4900099, 4900104, 4921474, 4921484, 5070049, 5223200, 5223202, 5223203, 5223208, 5223209, 5223217); 02-022-48-2013 (10885862306784; 4753825, 4850870, 4921468, 5109534, 5221923, 5221933, 5221940); 02-022-48-2509 (10885862306791; 4753834, 4753836, 4753844, 4907392, 4907393, 4907394, 4907395, 4984167, 5066987, 5066995, 5067004, 5067013, 5067015, 5067017, 5226634, 5226637, 5226645, 5226648, 5226650, Z058139); 02-022-48-2511 (10885862306807; 4750023, 4750028, 4764471, 4764474, 4764477, 4764479, 4921421, 5086291, 5123024, 5168530, 5219956, 5219963); 02-022-48-2513 (10885862306814; 4764974, 4905002, 4905010, 4905019, 5091444, 5091446, 5219805, 5219822, 5219826); 02-022-48-3009 (10885862306821; 4704027, 4704033, 4704034, 4704036, 4753064, 4753067, 4902259, 4902269, 4902274, 4902276, 4902281, 5063480, 5063483, 5063484, 5063485, 5118863, 5118867, 5118869, 5143513, 5143517, 5143520, 5143521, 5143524, 5143529, 5230466, 5230471, Z058160, Z058167); 02-022-48-3011 (10885862306838; 4712202, 4712203, 4712205, 4768621, 4768623, 4773505, 4773507, 4773509, 4773512, 4773513, 4921434, 4921441, 5066467, 5227156, 5227165, 5227166, 5227175, 5227178, 5227181); 02-022-48-3013 (10885862306845; 4703754, 4703759, 4764453, 4901803, 4901807, 4901810, 4901811, 4921367, 5227083, 5227087, 5227088, 5227103); 02-022-48-3509 (10885862306852; 4672392, 4672394, 4672396, 4672398, 4753016, 4753019, 4753020, 4753021, 4753025, 4907399, 4907400, 4907401, 4907406, 4907410, 5061658, 5061660, 5094590, 5094595, 5094597, 5094602, 5136197, 5136198, 5136202, 5136203, 5136207, 5136210, 5136213, 5212648, 5212651, 5212660, 5233310, 5233315, 5233323, 5233328, 5360303, 5360306, 5360308, 5360310, 5360315, 5360318, 5360319, 5360334, 5533086, 5533087, 5533088, 5533090, M007405, X7099654, X7099669); 02-022-48-3511 (10885862306869; 4672520, 4672526, 4764460, 4907445, 4907448, 4907454, 5063460, 5143571, 5144343, 5163398, 5351779, 5351784, 5351799, 5351802, 5351805, 5351808, M008593, M008599); 02-022-48-3513 (10885862306876; 4672543, 4672544, 4672549, 4672554, 4921359, 5063723, 5063731, 5226571, 5226580, 5226583, 5226584, 5226585); 02-022-48-4009 (10885862306883; 4703993, 4703996, 4703997, 4704001, 4704002, 4754712, 4754714, 4754716, 4754717, 4754719, 4754722, 4908445, 4908449, 4908452, 4908462, 4908463, 4908464, 4908465, 5097165, 5103263, 5103264, 5103265, 5103266, 5103271, 5103273, 5143468, 5143475, 5143479, 5171309, 5171315, 5386013, 5386023, 5386035, 5425459, 5425461, 5581668, M008389, M008398, M008400, X7099548, X7099570); 02-022-48-4011 (10885862306890; 4713624, 4713625, 4713626, 4713629, 4713634, 4777823, 4777827, 4777830, 4777833, 4908133, 4908135, 4908136, 5098224, 5098228, 5116903, 5116913, 5168513, 5168518, 5233805, 5233811, 5385996, 5386005, 5531319, M005561, M009247, M009253); 02-022-48-4013 (10885862306906; 4704006, 4704007, 4704012, 4760274, 4760281, 4908797, 4908804, 5116682, 5233433, 5233449, 5384342, 5384344); 02-022-48-4509 (10885862306913; 5036550, 5036557, 5036559, 5036570, 5085944, 5085946, 5085951, 5112493, 5112497, 5112500, 5128852, 5128853, 5137239, 5137245, 5191207, 5191210, 5191213, 5191220, 5267570, 5372615, 5622055, Z055159, Z057348); 02-022-48-4511 (10885862306920; 5035995, 5076978, 5076994, 5142568, 5233854, 5233870, 5385288, 5529797); 02-022-48-4513 (10885862306937; 5081163, 5255409); 02-022-48-5009 (10885862306944; 4712053, 4712057, 4712058, 4764152, 4764155, 4764156, 4764157, 4764158, 4764159, 4920771, 5077429, 5136533, 5136535, 5136541, 5136546, 5255184, 5255186, 5255198, 5378920, 5378933, 5378934, 5378939, 5390766, 5393211, 5531257, M008789); 02-022-48-5011 (10885862306951; 4712276, 4764215, 4764217, 4764221, 4908005, 5103311, 5103320, 5168550, 5233501, 5233502, 5233515, 5392345, M011118, M011119, Z055383); 02-022-48-5013 (10885862306968; 4715528, 4715529, 4765000, 4765009, 4901789, 4920697, 5071466, 5233331, 5252867, 5252869); c. Item Number (Device Identifier; Serial number(s)): 02-022-49-1009 (10885862307033; 4789814, 5226542); 02-022-49-1509 (10885862307064; 5036467, 5036473, 5036482, 5036483, 5063767, 5063771, 5085578, 5120158, 5249382); 02-022-49-1511 (10885862307071; 5037248, 5097115, 5097133); 02-022-49-2009 (10885862307095; 4757626, 4757630, 4757631, 4757632, 4850863, 4921575, 4921577, 4921583, 5103280, 5103285, 5132660, 5132663, 5221711, 5221730, 5221738, 5221740, 5384798); 02-022-49-2011 (10885862307101; 4673766, 4758315, 5217343, 5217348, 5217352); 02-022-49-2013 (10885862307118; 4757653, 5096970, 5220745); 02-022-49-2509 (10885862307125; 4673897, 4673899, 4673902, 4673904, 4673905, 4673906, 4764229, 4764231, 4764236, 4908374, 4908382, 4908385, 4921501, 4921502, 4921504, 5094118, 5094119, 5094131, 5094140, 5219984, 5219987, 5219989, 5220001, 5220003); 02-022-49-2511 (10885862307132; 4734276, 4734281, 4773484, 4773488, 4773492, 4922082, 5093059, 5093064, 5093074, 5093089, 5226425, 5226445, 5226452); 02-022-49-2513 (10885862307149; 4765851, Z052954); 02-022-49-3009 (10885862307156; 4737802, 4737804, 4737805,

Distribution pattern

device · product 6 of 9

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Z-0024-2022

Recall number: Z-0024-2022
Initiated: August 30, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Exactech, Inc.
Quantity: 2,217 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Code information

a. Item Number (Device Identifier; Serial number(s)): 350-21-01 (10885862276216; 4833710, 4833714, 4833715, 4833717, 4833723, 5188005, 5188007, 5188008, 5188009, 5188011, 5188013, 5188015, 5188017, 5188021, 5188022, 5188023, 5939820, 5939826, 5939831, 5939832, 5939833, 5939835, 5939836, 5939837, 5939838, 5939839, 5939840, 5939841, 5939842, 5939844, 5939845, 5939846, 6015553, 6015554, 6015556, 6015557, 6015560, 6015563, 6015566, 6015567, 6015569, 6396486, 6396489, 6396493, 6396495, 6396500, 6396504, 6396505, 6489379, 6489381, 6489382, 6489384, 6489386, 6606659, 6606667, 6606678, 6860126, 6860127, 6900582, 6900585, 6900588, Z060698, Z060703, Z060715, Z064072, Z064105, Z064107); 350-21-02 (10885862276223; 4536664, 4536665, 4536666, 4536668, 4536669, 4536670, 4536672, 4842955, 4842956, 4842957, 4842958, 4842959, 5184645, 5184647, 5184648, 5184649, 5184651, 5184652, 5184653, 5184654, 5184656, 5184657, 5184658, 5855814, 5855815, 5855816, 5855819, 5855820, 5855823, 5855824, 5855825, 5855826, 5855827, 5855828, 5855829, 5855830, 6240459, 6240461, 6240463, 6240464, 6240467, 6259881, 6259882, 6259884, 6259885, 6259888, 6356551, 6356552, 6356561, 6356562, 6356564, 6356566, 6356568, 6356569, 6356570, 6395847, 6395848, 6395852, 6395854, 6395855, 6395856, 6395858, 6395860, 6489055, 6489056, 6489059, 6489063, 6489065, 6489066, 6489069, 6489070, 6489071, 6489072, 6489073, 6583838, 6583839, 6583842, 6583843, 6583844, 6583845, 6583846, 6583849, 6583852, 6583853, 6583855, 6583857, 6730685, 6730688, 6730690, 6730696, 6730697, 6899729, 6899744, 6899751, Z068705, Z075029, Z075042); 350-21-03 (10885862276230; 4536738, 4536739, 4536740, 4536741, 4536742, 4536743, 4536745, 4536746, 4841023, 4841024, 4841025, 5184662, 5184663, 5184665, 5184666, 5184668, 5184669, 5184671, 5184672, 5184673, 5184674, 5184675, 5184678, 5184679, 5184680, 5221264, 5221265, 5221266, 5221267, 5221268, 5221269, 5221270, 5221272, 5221273, 5221274, 5221275, 5221276, 5940499, 5940500, 5940502, 5940507, 5940511, 5940516, 5940517, 5940518, 5940519, 5940520, 6039207, 6039208, 6039210, 6039212, 6039213, 6039214, 6039215, 6039218, 6039220, 6039221, 6039222, 6039223, 6039225, 6173447, 6173449, 6173450, 6173451, 6173452, 6173455, 6173456, 6173458, 6173459, 6173460, 6173462, 6173463, 6173464, 6173465, 6372717, 6372718, 6372719, 6372720, 6372721, 6372726, 6372727, 6372729, 6372730, 6372735, 6489128, 6489129, 6489131, 6489133, 6489134, 6489135, 6489136, 6489137, 6489145, 6489146, 6535721, 6535723, 6535724, 6535729, 6535730, 6535731, 6535732, 6535734, 6742242, 6742248, 6742249, 6742250, 6742251, 6742253, 6742255, 6742259, 6811600, 6811611, 6811612, 6900322, Z074962, Z074972, Z074984, Z075184); 350-21-04 (10885862276247; 4537204, 4537205, 4537206, 4537207, 4537212, 4750991, 5184539, 5184541, 5184543, 5184548, 5184550, 5184553, 5184554, 5184557, 5240718, 5240721, 5240727, 5240728, 5909332, 5909335, 5909337, 5909338, 5909344, 5909350, 5954808, 5954810, 5954815, 5954820, 6356463, 6356464, 6356466, 6356471, 6356472, 6356473, 6356477, 6489076, 6489081, 6489083, 6489093, 6758223, 6758226, 6758227, 6856945, 6856949, 6995782, Z068655); 350-21-11 (10885862276254; 4536710, 4536711, 4536714, 4536715, 4536716, 4536717, 4536718, 4704930, 4704938, 4704939, 4704940, 4704944, 4704945, 4704949, 4704951, 4704956, 4704957, 4787630, 4787631, 5184636, 5184639, 5184640, 5184643, 5231854, 5231855, 5231858, 5231860, 5969127, 5969128, 5969129, 5969132, 6356520, 6356523, 6489037, 6489045, 6489052); 350-21-12 (10885862276261; 4704789, 4771382, 4771383, 4771384, 4771387, 4771388, 5184684, 5184689, 5184690, 5184691, 5184697, 5184698, 5237420, 5237421, 5237422, 5237423, 5237424, 5237426, 5237430, 5237431, 5237432, 5939798, 5939801, 5939802, 5939803, 5939807, 5939810, 6356669, 6356670, 6356671, 6356672, 6356677, 6356680, 6356681, 6356683, 6356684, 6489360, 6489363, 6489365, 6489366, 6489369, 6489370, 6489372, 6598979, 6598980, 6598983, 6598985, 6843245, 6843247, 6843261, 6883796, Z058384, Z074986, Z074999); 350-21-13 (10885862276278; 4704790, 4771176, 4977232, 4977233, 4977235, 5181919, 5181921, 5181923, 5181926, 5181927, 5181931, 5181932, 5181934, 5222348, 5222349, 5222352, 5222355, 5222356, 5222357, 5222358, 5908535, 5908536, 5908537, 5908540, 5908541, 5908542, 5908544, 5908548, 5908549, 6061322, 6061327, 6323250, 6323261, 6395423, 6395424, 6395426, 6395428, 6488292, 6488297, 6488301, Z075109, Z075175); 350-21-14 (10885862276285; 4746009, 5184848, 5184851, 5184852, 5184853, 5184858, 5184860, 5184864, 5184865, 6143314, 6143323, 6143326, 6143329, 6143331, 6395394, 6395395, 6719894, Z076042); 350-21-21 (10885862276292; 4676330, 4676331, 4676332, 4676333, 4676334, 4676335, 4676336, 4676338, 4676345, 4676347, 4676351, 4676355, 5185107, 5185108, 5185110, 5185111, 5185113, 5185114, 5185117, 5185118, 5185119, 5245298, 5906409, 5906414, 5938419, 5938422, 5938424, 5938428, 6356532, 6356533, 6356537, 6356542, 6356549, 6486889, 6486890, 6486896, 6804245, 6900926); 350-21-22 (10885862276308; 4750965, 4771177, 5184866, 5184867, 5184870, 5184872, 5184873, 5184874, 5184878, 5184879, 5184880, 5184881, 5184883, 5876458, 5876461, 5876467, 6142807, 6142808, 6142811, 6142819, 6142825, 6411781, 6411784, 6428914, 6428917, 6428918, 6435219, 6435225, 6621519, 6621521, 6621524, 6621536, 6883664, 6883667, 6883671, 6959803, Z059779); 350-21-23 (10885862276315; 4771244, 4866126, 4866127, 4866129, 5172559, 5172560, 5172565, 5172566, 5172567, 5172569, 5172570, 5172572, 5172574, 5172577, 5172580, 5172581, 5172582, 5172583, 5172584, 5172588, 5172589, 5989847, 5989848, 5989849, 5989850, 5989853, 5989859, 5989861, 6408952, 6408954, 6408958, 6408959, 6408960, 6487891, 6487893, 6487895, 6487896, 6487897, 6487900, 6487902, 6487908, 6487909, 6644822, 6644825, 6644826, 6644831, 6644834, 6644835, 6644838, Z058458, Z058462, Z060686); 350-21-24 (10885862276322; 4536720, 4536721, 4536723, 4536724, 5185120, 5185127, 5185129, 5185132, 5185133, 5185134, 5185135, 5245294, 5245296, 5882353, 5882355, 5882358, 5882364, 5882365, 6142592, 6142601, 6142602, 6142605, 6142607, 6142608, 6396151, 6396156, 6851740, Z058435); 350-21-41 (10885862293213; 5181205, 5181206, 5181209, 5181210, 5181211, 5181212, 5181214, 5181215, 5181217, 5181218, 5181219, 5181222, 5954729, 5954730, 5954736, 5954745, 6409727, 6747749, 6747752, 6897935); 350-21-42 (10885862293220; 5184830, 5184831, 5184833, 5184837, 5184838, 5184839, 5184840, 5184844, 5184845, 5201342, 5201345, 5201349, 5909253, 5940479, 5940481, 5940482, 5940484, 5940487, 5940493, 5940495, 6143274, 6143276, 6143277, 6143282, 6143285, 6143286, 6143289, 6143292, 6396172, 6540417, 6540421, 6911569, Z059753); 350-21-43 (10885862293237; 5102165, 5102166, 5102171, 5102173, 5102174, 5102178, 5102179, 5102180, 5102183, 5230186, 5230190, 5230192, 5230196, 5230197, 5230199, 5230200, 5230203, 5912834, 5912837, 5912838, 5912840, 5912844, 5912846, 5912848, 6015723, 6015725, 6015728, 6395893, 6395900, 6571764, 6571775, 6860987, 6913035, Z077359); 350-21-44 (10885862293244; 5181165, 5181177, 5181178, 5967776, 5967781, 6325734, 6398023, 6424762, 6709425); 350-21-61 (10885862293374; 5185137, 5185147, 5909303); 350-21-62 (10885862293381; 6143359, 6143360, 6143368, 6143370, Z060582); 350-21-63 (10885862293398; 4733268, 5185157, 6487566); 350-21-64 (10885862293404; 5185168, 6143340, 6143348, 6488098); 350-22-01 (10885862276339; 4681920, 4681922, 4681923, 4681925, 4681927, 4681928, 4681930, 4681931, 4681932, 4681933, 4681934, 4681935, 4681937, 4681938, 4681940, 4681943, 4681945, 4681946, 4681948, 4681949, 5139951, 5139952, 5139953, 5139955, 5139956, 5139962, 5139963, 5139968, 5139970, 5139971, 5876391, 5876392, 5876393, 5876396, 5876398, 5876399, 5876403, 5876407, 5876412, 6127984, 6127985, 6127987, 6127993, 6127995, 6127997, 6128000, 6128003, 6395402, 6395406, 6395407, 6395410, 6395417, 6487092, 6487093, 6487094, 6487095, 6487097, 6487100, 6487102, 6487103, 6487106, 6487107, 6487108, 6487110, 6720137, 6720139, 6720142, 6720145, 6720146, 6720150, 6720152, 6720153, 6907877, 6907886, 6907887, 6907888, 6907892, 6907896, 6907899, 6907901, 6911587, 6911594, Z073322, Z073329); 350-22-02 (10885862276346, 4771234, 4771235, 4771236, 4771237, 4771238, 4771239, 4771240, 5181224, 5181225, 5181228, 5181229, 5181234, 5181235, 5181236, 5181237, 5181238, 5181239, 5181240, 5181241, 5181242, 5181244, 5245289, 5245290, 5245291, 5245292, 5245293, 5985462, 5985463, 5985464, 5985466, 5985468, 5985470, 5985471, 5985472, 5985473, 5985474, 5985475, 5985476, 5985477, 5985478, 5985480, 5985481, 6048026, 6048027, 6048028, 6048030, 6048031, 6067781, 6067782, 6067783, 6067785, 6067786, 6067787, 6067788, 6067790, 6067792, 6259896, 6259897, 6308445, 6308446, 6308447, 6308448, 6308451, 6308452, 6308454, 6308458, 6411977, 6411978, 6411979, 6411980, 6411981, 6411983, 6411984, 6411985, 6411989, 6434808, 6434811, 6434812, 6434813, 6434814, 6434816, 6434817, 6434818, 6434820, 6434821, 6434822, 6434823, 6434824, 6532890, 6532891, 6532895, 6532898, 6532899, 6532900, 6532902, 6532903, 6532904, 6532907, 6535639, 6535641, 6535643, 6535644, 6535645, 6535646, 6535649, 6535650, 6535651, 6535654, 6535657, 6758072, 6758073, 6758074, 6899905, 6899911, 6899914, 6899919, Z071104, Z071116, Z071136, Z076051); 350-22-03 (10885862276353; 4884296, 4884297, 4884298, 4884299, 5185183, 5185184, 5185187, 5185189, 5185190, 5185191, 5185192, 5185194, 5185195, 5185196, 5256071, 5256072, 5256073, 5256074, 5256075, 5256077, 5256078, 5256079, 5256080, 5938438, 5938439, 5938440, 5938441, 5938442, 5938447, 5938448, 5938451, 5938452, 5938453, 5938454, 5938456, 5938457, 5988014, 5988015, 5988016, 5988018, 5988019, 5988020, 5988022, 5988023, 5988025, 5988026, 5988027, 5988029, 5988030, 6252633, 6252634, 6252636, 6252638, 6252640, 6252641, 6285206, 6285207, 6285208, 6285210, 6285211, 6285212, 6285213, 6285215, 6340621, 6340630, 6340631, 6340632, 6340635, 6395438, 6395439, 6395440, 6395441, 6395444, 6395446, 6395451, 6395456, 6395457, 6482649, 6482650, 6482656, 6482662, 6482664, 6482665, 6509210, 6509214, 6509215, 6509216, 6509218, 6509219, 6509220, 6509223, 6509224, 6509227, 6683471, 6683474, 6683475, 6683477, 6683482, 6683485, 6683488, 6683492, 6718699, 6718707, 6718715, 6718716, 6852366, 6852367, 6852368, 6852375, 6852377, 6852379, 6853420, 6853427, 7010354, Z072696, Z073295); 350-22-04 (10885862276360; 5181310, 5181313, 5181314, 5181315, 5181317, 5181323, 5181327, 5262727, 5262729, 5262730, 5262731, 5262733, 5262735, 5262736, 5262737, 5907662, 5907666, 5907670, 5907671, 5907672, 5907673, 5907674, 5907676, 5967477, 5967482, 5967487, 5967488, 5967489, 5967491, 5967493, 5967494, 5967495, 6337400, 6337402, 6337406, 6337407, 6482499, 6502574, 6502576, 6502580, 6502586, 6502589, 6846082, 6846088, Z058442, Z058443, Z075357); 350-22-11 (10885862276377; 4703168, 4703171, 4703174, 4703177, 4703178, 4703179, 4703180, 4703183, 4703184, 4703187, 4703188, 4703190, 4703191, 4703192, 4703193, 4703194, 4703195, 4703196, 4703197, 4857844, 4857845, 4857846, 4857847, 5181328, 5181331, 5181336, 5181337, 5181338, 5181339, 5181341, 5181343, 5181345, 5954756, 5954758, 5954759, 5954761, 5954765, 6137105, 6137106, 6137115, 6137119, 6137121, 6372459, 6372468, 6372471, 6372474, 6372475, 6487131, 6487137, 6898086, Z075079); 350-22-12 (10885862276384; 4704788, 4771243, 5181347, 5181348, 5181349, 5181351, 5181352, 5181353, 5181354, 5181355, 5181356, 5181359, 5181360, 5181363, 5181364, 5193990, 5193991, 5193993, 5193995, 5193996, 5193997, 5193998, 5193999, 5194001, 5194002, 5194003, 5194004, 5882202, 5882208, 5882209, 5882210, 5882211, 5882212, 5882214, 5882215, 5882216, 5882218, 5882219, 5882282, 5882283, 5882284, 5882285, 5882286, 5882292, 5882295, 6356685, 6356691, 6356694, 6356695, 6356703, 6428946, 6489020, 6489021, 6489025, 6489026, 6489029, 6489031, 6502624, 6502629, 6502633, 6502634, 6683224, 6683231, 6898077, 6970223, 6970236, Z075900); 350-22-13 (10885862276391; 4771241, 4771242, 5120877, 5120882, 5120885, 5120886, 5120887, 5120889, 5204239, 5204240, 5204242, 5204244, 5204245, 5204247, 5204248, 5204250, 5204251, 5204252, 5939735, 5939741, 5939742, 5939744, 5939745, 5939746, 5939748, 5939749, 5939750, 5939751, 5939752, 5939753, 5939754, 6136641, 6136646, 6136649, 6136650, 6136651, 6428891, 6428893, 6489094, 6489097, 6489109, 6489124, 6489125, 6856921, 6856930, 6856931, Z058368, Z058370, Z074916); 350-22-14 (10885862276407; 5181368, 5181373, 5181374, 5181376, 5181380, 5181381, 5181383, 5906479, 5967548, 5967552, 5967553, 5967560, 5967564, 5967567, 6174579, 6174584, 6174589, 6569281, 6569289); 350-22-21 (10885862276414; 4703140, 4703141, 4703142, 4703143, 4703144, 4703147, 4703148, 4703149, 4703152, 4703154, 4703155, 4703156, 4703158, 4703160, 4703162, 4703163, 4703165, 4703167, 5185215, 5185216, 5185219, 5185221, 5185223, 5185225, 5185228, 5214261, 5214264, 5214265, 5939780, 5939788, 5939789, 6259901, 6395459, 6395470, 6591152, 6591161, 6591163); 350-22-22 (10885862276421; 4748658, 4771389, 5120893, 5120894, 5120895, 5120897, 5120898, 5120899, 5120900, 5120901, 5120902, 5120906, 5120907, 5120909, 5120912, 5120913, 5120914, 5120915, 5241242, 5241243, 5241244, 5241245, 5241246, 5241247, 5241248, 5241249, 5241250, 5241251, 5241252, 6015770, 6015777, 6015788, 6395920, 6487170, 6487175, 6487177, 6487179, 6487180, 6487181, 6742061, 6742065, 6742069, 6911514, Z075188, Z075281); 350-22-23 (10885862276438; 4771390, 4771392, 4771393, 4771394, 5181291, 5181294, 5181295, 5181296, 5181297, 5181299, 5181300, 5181301, 5181302, 5181303, 5181304, 5181305, 5181308, 5880510, 5880511, 5880514, 5880525, 5938089, 5938090, 5938091, 5938093, 5938096, 5938097, 5938099, 5938103, 5938105, 5938106, 5938107, 6395828, 6395831, 6395833, 6395837, 6395843, 6411724, 6411725, 6411726, 6411729, 6411730, 6411731, 6411735, 6411738, 6411741, 6506227, 6506228, 6506231, 6506234, 6506235, 6506239, 6506242, 6506243, 6734441, 6734442, 6734444, 6734447, 6734454, 6734455, 6870162, 6870183, 6870188, Z075253); 350-22-24 (10885862276445; 5181451, 5181453, 5181455, 5181458, 5181459, 5181464, 5232860, 5232861, 5232864, 5232867, 5232869, 5232870, 5232871, 5232874, 5232876, 5232877, 5907747, 5907751, 5939721, 5939727, 5939732, 6395493, 6395506, 6487126, 6487130, 6822884, 6822896, Z060416, Z069324); 350-22-41 (10885862293251; 5187946, 5187954, 5187956, 5907658, 5954768, 5954774, 5954779, 6396518, 6396521, 6489006); 350-22-42 (10885862293268; 5185783, 5185787, 5185788, 5185789, 5185790, 5185793, 5185794, 5185795, 5185799, 5185801, 5201264, 5201265, 5201266, 5201272, 5201273, 5201275, 5201276, 5201278, 5938401, 5938402, 5938404, 5938409, 5938411, 5938416, 6391264, 6483678, 6483684, 6483687, 6520721, 6520724, 6520725, 6520732, 6520733, 6520737, 6738668, 6738674, 6898015, 6898023, Z070796, Z070802); 350-22-43 (10885862293275; 5122629, 5122632, 5122635, 5122637, 5122638, 5122643, 5122645, 5122646, 5122648, 5260636, 5260638, 5260642, 5260643, 5260645, 5883315, 5883316, 5883324, 5940026, 5940027, 5940029, 5940033, 5940037, 5940038, 5940039, 5940041, 5940042, 6273558, 6273559, 6273562, 6273568, 6273570, 6412019, 6579440, 6579442, 6579443, 6579448, 6886404, Z060757); 350-22-44 (10885862293282; 5185203, 5185206, 5185209, 5967508, 5967510, 6417987, 6683339, 6737449); 350-22-62 (10885862293428; 5181465, 5181473, 5181484, 5948972, 5948990); 350-22-63 (10885862293435; 5181395, 5906439, 5906440, 6409703, 6409711, 6409712, Z077335); 350-22-64 (10885862293442; 5181406, 5181407, 5181414, 5181421, 5975072, 5975080); b. Item Number (Device Identifier; Serial number(s)): 350-41-01 (10885862276452; 4851797, 4851798, 4851799, 4851800, 4964108, 4986270, 5194348, 5194350, 5194353, 5194356, 5194357, 5194358, 6409670, 6506001, 6506009, 6857644, 6857646, 6857652); 350-41-02 (10885862276469; 4850102, 4850103, 4850104, 4850105, 4963948, 4963951, 5194275, 5194276, 5194277, 5194279, 5194280, 5194281, 5194282, 5194283, 5194285, 5194286, 5194287, 5194288, 5194289, 5194290, 5194291, 5194292, 5865068, 5865072, 5865073, 5865076, 5865081, 5865086, 5865087, 5865089, 6330721, 6330728, 6330732, 6507180, 6507186, 6507198, 6592234, 6592235); 350-41-03 (10885862276476; 4851814, 4851816, 4963859, 4963860, 4963862, 5181425, 5181426, 5181428, 5181430, 5181432, 5181433, 5181434, 5181435, 5181436, 5181438, 5181440, 5181441, 5181443, 5181444, 6138428, 6409639, 6409640, 6409644, 6409647, 6409650, 6409651, 6409652, 6409658, 6535259, 6535265, 6535268, 6900013); 350-41-04 (10885862276483; 4851782, 4851783, 4851784, 4913716, 5193807, 5193811, 5193813, 5193819, 6143103, 6143110, 6506247, 6506251, 6506260, 6506262, 6506263); 350-41-05 (10885862302038; 5192099); 350-41-11 (10885862276490; 4851670, 4851671, 4851672, 4963858, 5194262, 5194265, 5194268, 5194274, 6506369, 6506380); 350-41-12 (10885862276506; 4850106, 4850107, 4850108, 4850109, 4913690, 4913691, 4913693, 5194293, 5194294, 5194297, 5194304, 5194307, 6505962, 6505963, 6505968, 6566991, 6566994, 6566999, 6567000); 350-41-13 (10885862276513; 4850078, 4850079, 4850080, 4850081, 4963842, 5194329, 5194331, 5194333, 5194334, 5194336, 5194338, 5194339, 5194342, 5194345, 6141325, 6141326, 6141329, 6439029, 6439031, 6439041, 6825226); 350-41-14 (10885862276520; 4851603, 4913723, 4913724, 4913725, 5193794, 5193795, 5193798, 5193806, 6143269, 6776618, 6776626); 350-41-15 (10885862302045; 5194254); 350-41-21 (10885862276537; 4850098, 4850099, 4850100, 4963849, 4963850, 4963852, 5205336, 5205342, 5205346, 5205347, 6506333, 6506347); 350-41-22 (10885862276544; 4851637, 4851638, 4851639, 4851640, 4930455, 4930456, 4930458, 4930460, 5250981, 5250983, 5250985, 5250986, 5250987, 5250988, 6143140, 6507141, 6922888, Z081039); 350-41-23 (10885862276551; 4850110, 4850111, 4850112, 4913660, 4913661, 4913662, 4913663, 5194236, 5194237, 5194239, 5194240, 5194246, 5194247, 5194248, 5194250, 5194251, 5194252, 6141292, 6141293, 6466622, 6504528, 6504529, 6775088, 6775098, 6775102); 350-41-24 (10885862276568; 4850094, 4850095, 4850096, 4850097, 4963769, 4963772, 5184563, 5184566, 5184568, 5184571, 5184576, 6141203, 6505950, 6505958); 350-41-25 (10885862302052; 5194176, 5194177); 350-41-41 (10885862293534; 4851727, 4963764, 4963765, 5194226, 5194231); 350-41-42 (10885862293541; 4850090, 4850091, 4850092, 4850093, 4963759); 350-41-43 (10885862293558; 4851761, 4851763, 4963777, 4963778, 4963780, 5194201, 5194203, 5194206, 5194212, 5194215, 5194216, 6143085, 6506501); 350-41-44 (10885862293565; 4851693, 4963661, 4963662, 5193851, 5193852, 6139778, 6139786); 350-41-45 (10885862302076; 5194180); 350-41-61 (10885862293695; 4851597, 4851598); 350-41-62 (10885862293701; 4851588, 4963649, 5194100); 350-41-63 (10885862293718; 4851593, 4851594); 350-41-64 (10885862293725; 4851599, 4851600, 5194096); 350-41-65 (10885862302090, 5194116, 5194118); 350-42-01 (10885862276575; 4851765, 4851766, 4851767, 4851768, 4962062, 4962065, 4962067, 5181941, 5181942, 5181945, 5181948, 5181949, 5181951, 5181955, 5181956, 5181957, 6504541, 6504544, 6504545, 6504547, 6504548, 6504550, 6813572, 6813577, 7009630); 350-42-02 (10885862276582; 4847130, 4847131, 4847132, 4962961, 4962964, 4962965, 5194138, 5194139, 5194140, 5194141, 5194143, 5194145, 5194147, 5194149, 5194150, 5194152, 5194153, 5194155, 5910497, 5910507, 6442342, 6442348, 6442351, 6506023, 6506024, 6506029, 7011500); 350-42-03 (10885862276599; 4847207, 4847208, 4847209, 4847210, 4863354, 4863355, 4863356, 4863357, 4863358, 4863359, 4863360, 5229805, 5229806, 5229807, 5229809, 5229812, 5229813, 5229815, 5229817, 5229819, 5229820, 5229821, 5229822, 6070811, 6070812, 6356277, 6356281, 6356282, 6356284, 6356286, 6356288, 6356289, 6356292, 6356293, 6356295, 6570281, 6570284, 6570291, 6570292, 6570297, 6862327, 6862328, 6862329, 6862332, 6862333); 350-42-04 (10885862276605; 4847172, 4847173, 4847174, 4914356, 4914359, 4959353, 4959356, 4959357, 5245932, 5245934, 5245935, 5245936, 5245938, 5245939, 5245942, 5245944, 6095443, 6095450, 6095453, 6095455, 6505375, 6505376, 6505383, 6505384, 6505385, 6505390, 6505392); 350-42-05 (10885862302106; 5192871); 350-42-11 (10885862276612; 4851829, 4851830, 4851831, 4851832, 4962030, 5192065, 5192067, 5192070, 5192071, 5192075, 5192077, 6143134, 6506128, 6506130, 6981225); 350-42-12 (10885862276629; 4847136, 4847137, 4914322, 4914323, 4914325, 4959360, 4959361, 4959363, 4959364, 5234643, 5234651, 5234652, 5234654, 6138480, 6138483, 6138489, 6505702, 6505703, 6505708, 6505709, 6505711, 6861040, 6861055); 350-42-13 (10885862276636; 4851580, 4851581, 4851582, 4959342, 4959346, 5181960, 5181961, 5181963, 5181964, 5181965, 5181966, 5181967, 5181970, 5181971, 5181972, 5181974, 5181975, 5181976, 5181977, 6143249, 6143253, 6456685, 6456692, 6456695, 6456703, 6591960, 6591961, 6591962, 6982233, 6982235, 6982236, Z081206, Z081219, Z081222); 350-42-14 (10885862276643; 4851584, 4851586, 4914362, 4914363, 4914364, 4914365, 4959348, 4959350, 5247865, 5247867, 5247870, 5247876, 6095825, 6095826, 6095835, 6458504, 6504558, 6504563, 6795422, 6795424); 350-42-15 (10885862302113; 5192877, 5192879); 350-42-21 (10885862276650; 4851469, 4851470, 4851471, 4851472, 4959335, 5192816, 5192820, 5192822, 6143099, 6143102, 6505394, 6505399, 6505404, 6505407, 6505409, 6505410); 350-42-22 (10885862276667; 4851477, 4851478, 4851479, 4851480, 4963995, 5192850, 5192851, 5192852, 5192853, 5192854, 5192855, 5192856, 5192857, 5192859, 5192862, 5192864, 5192865, 5192866, 6013085, 6013087, 6013088, 6504632, 6504637, 6504640, 6504641, 6900864); 350-42-23 (10885862276674; 4850086, 4850087, 4850088, 4850089, 4915608, 4915609, 4915610, 4959366, 4959367, 4959368, 4959369, 4959370, 5247851, 5247852, 5247853, 5247855, 5247857, 5247861, 6140620, 6140624, 6140626, 6505022, 6505024, 6505035, 6505037); 350-42-24 (10885862276681; 4851474, 4851476, 4964102, 4964105, 4964106, 5192835, 5192837, 5192841, 5192842, 6505078, 6505084, 6505086, 6505090, 6505093, 6505094, 6505095); 350-42-25 (10885862302120; 5192873); 350-42-41 (10885862293572; 4851484, 4964051, 4964054, 4964055, 6140502, 6505414, 6505426, 6505429); 350-42-42 (10885862293589; 4851486, 4851487, 4851488, 4964095, 4964096, 4964097, 5192764, 5192765, 5192771, 5192777, 6143120, 6566946, 6566948); 350-42-43 (10885862293596; 4851501, 4851502, 4851503, 4851504, 5192747); 350-42-44 (10885862293602; 4850481, 4850482, 4850484, 4964061, 5192734); 350-42-45 (10885862302144; 5192492); 350-42-61 (10885862293732; 4850491, 4964127, 4964130); 350-42-62 (10885862293749; 4850477, 4850479, 5193940); 350-42-63 (10885862293756; 4850485, 4850486, 4850488, 5194360, 6138511); 350-42-64 (10885862293763; 4964131, 4964133, 5194389, 5194394); 350-42-65 (10885862302168, 5192508);

Distribution pattern

device · product 7 of 9

OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Z-0025-2022

Recall number: Z-0025-2022
Initiated: August 30, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Exactech, Inc.
Quantity: 33,103 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Code information

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, 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3711023, 3730761, 3730763, 3730764, 3730765, 3730767, 4040958, 4040959, 4040960, 4040961, 4040962, 4040964, 4040965, 4040966, 4040967, 4040968, 4040969, 4040970, 4040971, 4040972, 4383791, 4383793, 4383794, 4383795, 4383796, 4383797, 4383798, 4383802, 4383803, 4383804, 4383805, 4383806, 4383807, 4383811, 4383817, 4383818, 4848740, 4848744, 4848746, 4848748, 4848751, 4848755, 4848756, 4848758, 4848759); 264-21-13 (10885862068866; 0756929, 0756930, 0756931, 0756932, 0756934, 0756935, 0756936, 0756937, 0756939, 0756940, 0756941, 0756942, 0756943, 0756944, 0756946, 0756947, 0756948, 0756949, 0756950, 0756951, 0756952, 0782192, 0782193, 0782194, 0782196, 0782197, 0782198, 0782199, 0782200, 0782201, 0782202, 0782203, 0782204, 0782205, 0782206, 0782207, 0782208, 0782209, 0782210, 0782211, 0782212, 0782213, 0782214, 0782215, 0782216, 0782217, 0782218, 0824956, 0824957, 0824958, 0824959, 0824960, 0824961, 0824962, 0824963, 0824964, 0824965, 0824966, 0824969, 0824971, 0824972, 0824973, 0824975, 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1719909, 1719910, 1719911, 1719912, 1719914, 1719915, 1719916, 1719918, 1719920, 1719921, 1719922, 1719924, 1719925, 1719927, 1719929, 1719930, 1719931, 1719932, 1719933, 1719934, 1735881, 1735882, 1735885, 1735886, 1735887, 1735888, 1735891, 1735894, 1735895, 1735896, 1735897, 1735898, 1735899, 1735901, 1735902, 1735903, 1735904, 1735905, 1735906, 1735907, 1735909, 1944485, 1944486, 1944487, 1944488, 1944489, 1944491, 1944493, 1944494, 1944497, 1944498, 1944499, 1944500, 1944501, 1944503, 2015902, 2015904, 2015905, 2015907, 2015908, 2015909, 2033108, 2042975, 2042976, 2042977, 2043971, 2043973, 2043974, 2043975, 2043976, 2043977, 2043978, 2043979, 2043980, 2043981, 2043983, 2123211, 2123212, 2123213, 2123214, 2123215, 2123217, 2123218, 2123219, 2123220, 2123221, 2319856, 2319859, 2319863, 2375585, 2375586, 2375589, 2375590, 2375591, 2375593, 2375596, 2375597, 2375598, 2503058, 2503059, 2503060, 2503061, 2503063, 2576101, 2576102, 2576103, 2893213, 2893214, 2893215, 2893216, 2893217, 2893218, 2893219, 2893220, 2893221, 2893222, 2893223, 2893224, 2893225, 2893226, 2893227, 2991780, 2991783, 2991784, 2991785, 2991786, 2991788, 3634569, 3634572, 3634573, 3659956, 3659957, 3659958, 3659959, 3659960, 3659961, 3659962, 3659963, 3674499, 3674500, 3674503, 3683837, 3683838, 3683839, 3683840, 3683841, 3683842, 3683843, 3730752, 3730753, 3730754, 3730755, 3782163, 3782164, 3782165, 3952770, 3952771, 3952772, 3952773, 3952774, 3952775, 3952776, 4021745, 4021746, 4080577, 4080578, 4080579, 4080580, 4080582, 4080583, 4080585, 4360120, 4360121, 4360122, 4360123, 4360124, 4360126, 4360127, 4360128, 4360129, 4360131, 4360134, 4360135, 4360136, 4360137, 4360138, 4360139, 4733352, 4733353, 4848686, 4848687, 4848689, 4848693, 4848698, 4848699, 4848701, 4848702, 4848704, 4848705, 4848708); 264-21-15 (10885862068873; 0989743, 0989744, 0989745, 0989746, 0989747, 0989748, 0989749, 0989750, 0989751, 0989752, 0989755, 0989757, 0989759, 0989760, 0989761, 0989763, 0989764, 0989765, 0989767, 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2146456, 2146457, 2348726, 2348729, 2348733, 2348734, 2348735, 2348736, 2348738, 2479741, 2479742, 2479744, 2479745, 2479746, 2479748, 2479749, 2479751, 2479753, 2479755, 2910404, 2910405, 2910406, 2910407, 2910409, 2910411, 2910412, 2971643, 2971644, 2992195, 2992196, 2992197, 2992198, 3566394, 3566399, 3634578, 3634579, 3660809, 3660810, 3660811, 3660815, 3660816, 3660817, 3660818, 3660819, 3660821, 3660822, 3777922, 3777923, 3777924, 3777927, 3777930, 3777931, 4337551, 4337552, 4337554, 4510735, 4510740, 4884726, 5678957, 5678961, 5678962, 5678963, 5678964); 264-22-09 (10885862068880; 0781992, 0781993, 0781994, 0781995, 0781996, 0781997, 0781998, 0781999, 0782000, 0782001, 0782002, 0782003, 0782004, 0782005, 0782006, 0782007, 0782008, 0782009, 0782010, 0782011, 0782012, 0782013, 0782014, 0782015, 0782016, 0782017, 0782018, 0782019, 0782020, 0782021, 0782022, 0782023, 0782024, 0782025, 0782026, 0782027, 0782028, 0782029, 0782030, 0782031, 0782032, 0782033, 0782034, 0782035, 0782036, 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Distribution pattern

device · product 8 of 9

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.

Z-0026-2022

Recall number: Z-0026-2022
Initiated: August 30, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Exactech, Inc.
Quantity: 8,985 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Code information

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, 4706384, 4706385, 4706386, 4706387, 4706389, 4706390, 4766526, 4766527, 4766528, 4766529, 4766530, 4766531, 4766532, 4766533, 4766534, 4901264, 4901265, 4901268, 4901269, 5080411, 5080412, 5080413, 5080415, 5080416, 5080417, 5080418, 5080419, 5080420, 5977948, 5977950, 6112212, 6112218, 6112224, 6112225, 6112226, 6112227, 6112228, 6112229, 6112231, 6561879, 6561886, 6561890, 6561891, 6561892, 6561894, 6561896); 02-012-38-1011 (10885862002365; 2113460, 2113461, 2113462, 2113465, 2113466, 2113467, 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4143274, 4143275, 4143276, 4143277, 4476031, 4476032, 4476033, 4476034, 4476035, 4476036, 4476037, 4476038, 4476039, 4476040, 4476041, 4476043, 4476044, 4476045, 4476046, 4476047, 4476048, 4476050, 4476051, 4476052, 4476053, 4476054, 4476057, 4476060, 5236236, 5236238, 5882865, 5882867, 5882869, 5882871, 5882872); 02-012-38-1013 (10885862002372; 2112936, 2112937, 2112939, 2112942, 2112943, 2112945, 2112947, 2112948, 2112949, 2112950, 2112951, 2112952, 2112954, 2112956, 2112957, 2112959, 2112960, 2112962, 2112964, 2112966, 2362197, 2362198, 2362200, 2362205, 2362207, 2573351, 2573353, 2917120, 2917121, 2917124, 2917125, 2917126, 2917127, 2917128, 2917130, 2917131, 3615834, 3615835, 3615841, 3615842, 3826036, 3826037, 3826039, 3826041, 3826043, 3989617, 3989618, 3989619, 3989624, 4152499, 4152504, 4152505, 4152506, 4152510, 4152512, 4152514, 4152521, 5981031, 6411707); 02-012-38-1015 (10885862002389; 2112584, 2112588, 2112594, 2112596, 2112598, 2112600, 2112602, 2573354, 2573355, 2778422, 2901287, 2901289, 2901290, 2901293, 2901294, 3870048, 3870049, 3870051, 3870052, 3991107, 4120497, 4217789, 4217795, 4217813); 02-012-38-1509 (10885862178794; 3616081, 3616082, 3616083, 3616084, 3795243, 3795244, 3795245, 3795247, 3795248, 3836262, 3873433, 4310727, 4310729, 4310730, 4310731, 4310733, 4310734); 02-012-38-1511 (10885862178800; 3607850, 3662935, 3662937, 4259564, 4259566, 4259568, 4259570, 4259572); 02-012-38-1513 (10885862178817; 3873426, 4259573); 02-012-38-2009 (10885862002396; 2113395, 2113396, 2113397, 2113398, 2113399, 2113401, 2113402, 2113403, 2113404, 2113405, 2113406, 2113407, 2113408, 2113409, 2113410, 2113411, 2113412, 2113413, 2113414, 2113415, 2113416, 2113417, 2113418, 2113419, 2113420, 2113421, 2113422, 2113423, 2180482, 2180483, 2180484, 2180485, 2180486, 2180487, 2180488, 2180489, 2180490, 2180491, 2211710, 2211711, 2211712, 2211713, 2211714, 2211715, 2211716, 2211717, 2211718, 2275541, 2275542, 2275543, 2275544, 2275545, 2275546, 2288266, 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6593569, 6820101, 6820103, 6820109, 6820110, 6820116, 6820117, 6820134, Z079469, Z079472, Z079474, Z079475, Z079484, Z079487, Z079489, Z079495, Z079502, Z079503, Z079523, Z079529, Z082267); 02-012-38-2011 (10885862002402; 2109516, 2109517, 2109518, 2109519, 2109520, 2109521, 2109522, 2109523, 2109524, 2109525, 2109526, 2109527, 2109528, 2109529, 2109530, 2109531, 2109532, 2109533, 2109534, 2109535, 2109536, 2109537, 2109538, 2109539, 2109540, 2109541, 2109542, 2109543, 2109544, 2190754, 2190755, 2190756, 2190757, 2190758, 2190759, 2190760, 2190761, 2190762, 2190763, 2257155, 2257156, 2257157, 2257158, 2257159, 2257160, 2288280, 2288281, 2288282, 2288283, 2288284, 2288285, 2288286, 2288287, 2352839, 2352840, 2352841, 2352842, 2352843, 2352844, 2352845, 2352846, 2352847, 2352848, 2352849, 2352850, 2352851, 2352852, 2352853, 2352854, 2352855, 2352856, 2352857, 2352858, 2352859, 2352860, 2352861, 2352862, 2352863, 2352864, 2352865, 2352866, 2352867, 2352868, 2516096, 2516097, 2516098, 2516099, 2516100, 2516101, 2516102, 2516103, 2516104, 2516105, 2516106, 2516107, 2516108, 2516109, 2516110, 2516111, 2516112, 2516113, 2573356, 2573357, 2573358, 2573359, 2573360, 2573361, 2573362, 2573363, 2573364, 2573365, 2707750, 2707751, 2707752, 2707753, 2778394, 2778395, 2778396, 2778397, 2778398, 2778399, 2778400, 2778401, 2778402, 2778403, 2778404, 2778405, 2778406, 2778407, 2778408, 2901324, 2901325, 2901326, 2901327, 2901328, 2901329, 2901330, 2901331, 2901332, 2901333, 2901334, 2901335, 2901336, 2901337, 2901338, 2901339, 2901340, 2901341, 2901342, 2901343, 2901344, 2939340, 2939341, 2939342, 2939343, 2939344, 2939345, 2939346, 2939347, 2939348, 2939349, 2939350, 2939351, 2939352, 2939354, 2939355, 2939356, 2939357, 2939358, 2939359, 2993455, 2993457, 2993458, 2993459, 2993460, 2993461, 2993462, 2993463, 2993464, 2993465, 2993466, 2993467, 2993468, 2993469, 3733026, 3733027, 3733028, 3733029, 3733030, 3733031, 3733032, 3733033, 3733034, 3733035, 3733037, 3733038, 3733039, 3826200, 3826201, 3826202, 3826203, 3826204, 3826205, 3826207, 3826208, 3826209, 3826210, 3826211, 3826212, 3826213, 3826214, 3826215, 3826216, 3826217, 3826218, 3826219, 3875877, 3875878, 3875879, 3875880, 3875881, 3875882, 3875883, 3875884, 3875885, 3875886, 3959196, 3959197, 3959198, 3959199, 3959200, 3959201, 3959202, 3959203, 3959204, 3959205, 3959206, 3959207, 3959208, 3959209, 3959210, 3959211, 3959212, 3959214, 3959215, 3959216, 3959217, 3959218, 3959219, 3959220, 3959221, 3959222, 3959223, 3959224, 3959225, 4023436, 4023437, 4023438, 4023439, 4023440, 4023441, 4023442, 4023443, 4023444, 4023445, 4023446, 4023447, 4023448, 4023449, 4023450, 4023451, 4023452, 4023453, 4023454, 4023455, 4023456, 4023457, 4023458, 4023459, 4023460, 4023461, 4023462, 4023463, 4023464, 4023465, 4105285, 4105286, 4105287, 4105288, 4105289, 4105290, 4105291, 4105292, 4105293, 4105294, 4181279, 4181280, 4181281, 4181282, 4181283, 4181284, 4181285, 4181286, 4181287, 4181288, 4181289, 4181290, 4181291, 4181292, 4181293, 4181294, 4181295, 4181296, 4181297, 4181298, 4217819, 4217820, 4217821, 4217822, 4217823, 4217824, 4217825, 4217826, 4217827, 4217828, 4217829, 4217830, 4217831, 4217832, 4217833, 4217834, 4217835, 4217836, 4217837, 4217838, 4217839, 4217840, 4217841, 4217842, 4217843, 4217844, 4217845, 4217846, 4217848, 4335712, 4335713, 4335714, 4335715, 4335716, 4335717, 4335718, 4335719, 4335720, 4335721, 4335722, 4335723, 4335724, 4335725, 4335726, 4335727, 4335728, 4335729, 4335730, 4335731, 4335732, 4335733, 4335734, 4335735, 4335736, 4335737, 4335738, 4335739, 4335740, 4335741, 4683277, 4683278, 4683279, 4683280, 4683281, 4683282, 4683283, 4683284, 4683285, 4683286, 4683287, 4683288, 4683289, 4683290, 4683291, 4683292, 4683293, 4683294, 4683295, 4683296, 4683297, 4683298, 4683299, 4683300, 4683301, 4683302, 4683303, 4683304, 4683305, 4683306, 4905541, 4905542, 4905543, 4905544, 4905545, 4905546, 4905547, 4905548, 4905549, 4905550, 4950674, 4950675, 4950676, 4950677, 4950678, 4950679, 4950680, 4950681, 4950682, 4950683, 4981656, 4981657, 4981658, 4981659, 4981660, 4981661, 4981662, 4981663, 4981664, 4981665, 5084587, 5084588, 5084589, 5084590, 5084591, 5084592, 5084593, 5084594, 5084595, 5084596, 5100906, 5100907, 5100908, 5100909, 5100910, 5100911, 5100912, 5100913, 5100914, 5100915, 5177124, 5177125, 5177126, 5177127, 5177128, 5177129, 5177130, 5177131, 5177132, 5247687, 5247688, 5247689, 5247690, 5247691, 5247692, 5247693, 5247695, 5247696, 5247697, 5247698, 5247699, 5247700, 5247701, 5247702, 5247703, 5247704, 5247705, 5247706, 6025944, 6025949, 6025950, 6025951, 6025952, 6025953, 6025955, 6025956, 6025957, 6025959, 6025960, 6025963, 6025967, 6025968, 6025970, 6025971, 6044284, 6044285, 6044286, 6044287, 6044288, 6044289, 6044291, 6044292, 6044293, 6044294, 6044296, 6044298, 6044299, 6044302, 6044303, 6044305, 6044308, 6044310, 6044311, 6044312, 6524495, 6524496, 6524498, 6524499, 6524500, 6524503, 6524504, 6524505, 6524509, 6524516, 6524517, 6524522, 6524523, 6595695, 6595697, 6595698, 6595701, 6595706, 6595720, 6595722, 6595726, 6595728, 6595729, 6595730, 6710096, 6710107); 02-012-38-2013 (10885862002419; 2113196, 2113197, 2113198, 2113199, 2113200, 2113201, 2113202, 2113203, 2113204, 2113205, 2113207, 2113208, 2113209, 2113210, 2113211, 2113212, 2113213, 2113214, 2113215, 2113216, 2113217, 2113218, 2113219, 2113220, 2113221, 2113222, 2113223, 2113225, 2113226, 2113227, 2113228, 2113229, 2292182, 2292183, 2292184, 2292185, 2292186, 2292187, 2360965, 2360966, 2360967, 2360969, 2360970, 2360971, 2360972, 2360973, 2360974, 2360975, 2360976, 2360977, 2360978, 2562066, 2562067, 2562068, 2562069, 2562070, 2562071, 2562072, 2562073, 2562074, 2709090, 2709091, 2775040, 2775041, 2775043, 2775044, 2775047, 2775048, 2775049, 2954911, 2954912, 2954913, 2954914, 2954915, 2954916, 2993452, 2993453, 2993454, 3533850, 3533851, 3533852, 3533853, 3533854, 3533855, 3533856, 3533857, 3615843, 3615844, 3615845, 3615847, 3615848, 3615850, 3615852, 3652362, 3652363, 3652364, 3652365, 3652366, 3652367, 3652368, 3652370, 3826045, 3826046, 3826047, 3826048, 3826052, 3826053, 3826054, 3955539, 3955540, 3955541, 3955542, 3955543, 3955545, 3955546, 3955547, 3955548, 3987370, 3987371, 3987372, 3987373, 3987374, 3987375, 3987376, 3987377, 3987378, 3987379, 4045894, 4045895, 4045896, 4045897, 4045898, 4045899, 4045900, 4045901, 4045902, 4045903, 4123762, 4123763, 4123764, 4167272, 4167273, 4167274, 4167275, 4167276, 4167277, 4167278, 4167279, 4167280, 4167281, 4167282, 4167283, 4167284, 4167285, 4167286, 4167287, 4167288, 4167289, 4167290, 4167291, 4167292, 4167293, 4167294, 4167295, 4167296, 4167297, 4337793, 4337795, 4337796, 4337797, 4337798, 4337799, 4337800, 4337801, 4337802, 4475983, 4475984, 4475985, 4475988, 4475991, 4475993, 4475994, 4475995, 4475997, 4475998, 4475999, 4476000, 4476001, 5033698, 5033699, 5033700, 5033701, 5033702, 5098710, 5098711, 5098712, 5098713, 5098714, 5098715, 5098716, 5098717, 5098718, 5098719, 5198669, 5198670, 5198671, 5198672, 5198673, 5198674, 5198675, 5198676, 5198678, 5836988, 5836990, 5836991, 5836997, 5837001, 5900114, 5900121, 5900123, 5900125, 5900126, 5900129, 5900133, 5900137, 6595492, 6595507); 02-012-38-2015 (10885862002426; 2113339, 2113341, 2113342, 2113343, 2113347, 2113348, 2113349, 2113350, 2113354, 2113355, 2113356, 2113358, 2113362, 2113363, 2113365, 2113367, 2113369, 2113370, 2256234, 2256238, 2256240, 2256241, 2558677, 2558678, 2558682, 2558683, 2558684, 2558687, 2558688, 2558689, 2558692, 2558693, 2954917, 2954920, 2954922, 3523349, 3523351, 3523354, 3523356, 3523358, 3523360, 3523363, 3523364, 4046830, 4046831, 4046832, 4046834, 4046836, 4046837, 4046838, 4305195, 4305197, 4305199, 4305201, 4305210, 6315859); 02-012-38-2509 (10885862178831; 2583863, 2583864, 2583865, 2583866, 2583867, 2583868, 2583869, 2583870, 2974666, 2974667, 2974668, 2974669, 2974670, 2985580, 2985581, 2985582, 2985583, 2985584, 2985585, 2985586, 2985587, 2985588, 2985589, 2985590, 2985591, 2985592, 2985593, 2985594, 2985595, 2985596, 2985597, 3621198, 3621199, 3621200, 3621201, 3621202, 3621203, 3705279, 3795250, 3826223, 3826224, 3826225, 3826227, 3826228, 3826229, 3826230, 3826231, 3826232, 3875868, 3875869, 3875870, 3875871, 3875872, 3875873, 3875874, 3875875, 3875876, 3988409, 3988410, 3988411, 3988412, 3988413, 3988414, 3988417, 3988418, 3988419, 3988420, 3988421, 3988422, 3988423, 3988424, 3988425, 3988426, 3988427, 3988428, 4045852, 4045853, 4045854, 4045855, 4045857, 4045858, 4045859, 4045860, 4045861, 4045862, 4045863, 4045865, 4045866, 4067160, 4067161, 4067162, 4067163, 4067164, 4067165, 4067166, 4067167, 4067168, 4067169, 4067170, 4067171, 4067172, 4067173, 4067174, 4067175, 4067176, 4067177, 4067178, 4067179, 4067180, 4067181, 4067182, 4067183, 4067184, 4217849, 4217850, 4217851, 4217854, 4217856, 4217857, 4217858, 4217859, 4217860, 4217861, 4217862, 4217863, 4217864, 4217865, 4217866, 4217867, 4217868, 4217869, 4217870, 4217871, 4217872, 4217873, 4217874, 4217875, 4217876, 4217877, 4217878, 4373437, 4373439, 4373441, 4373442, 4373443, 4373444, 4373445, 4373446, 4373447, 4373449, 4373450, 4373451, 4373452, 4373453, 4373454, 4373455, 4373456, 4683307, 4683308, 4683309, 4683310, 4683311, 4683312, 4683313, 4683314, 4683315, 4683316, 4683317, 4683318, 4683319, 4683320, 4683321, 4683322, 4683323, 4683324, 4683325, 4683326, 4820145, 4820146, 4820147, 4820148, 4820149, 4820150, 4820151, 4820152, 4820153, 4820154, 4867612, 4867613, 4867614, 4867615, 4867616, 4867617, 4867618, 4867619, 4867620, 4867621, 4905592, 4905593, 4905594, 4905595, 4905596, 4905597, 4905598, 4905600, 4905601, 4905602, 4905603, 4905604, 4905605, 4905606, 4905607, 4905608, 4905609, 4905610, 4905611, 4992232, 4992233, 4992234, 4992235, 4992236, 4992237, 4992238, 4992239, 4992240, 4992241, 5087448, 5087449, 5087451, 5087452, 5087453, 5087454, 5087455, 5087456, 5087457, 5145634, 5145635, 5145636, 5145637, 5145638, 5145639, 5145640, 5145641, 5145642, 5145643, 5933519, 5933521, 5933522, 5933523, 5933525, 5933526, 5933527, 5933528, 5933529, 5933530, 5933531, 5933532, 5933533, 5933536, 5933537, 5933538, 5933540, 5933542, 5933543, 5933544, 5933545, 5933546, 5933547, 5933548, 6030049, 6030050, 6030051, 6030053, 6030054, 6030055, 6030056, 6030057, 6030060, 6030061, 6030062, 6030063, 6030064, 6030066, 6030067, 6030068, 6030069, 6030072, 6030073, 6030074, 6030075, 6030076, 6309392, 6309393, 6309394, 6309397, 6309399, 6309400, 6309401, 6309402, 6309405, 6309406, 6309408, 6309410, 6309412, 6309413, 6309418, 6309419, 6309420, 6309421, 6528939, 6528940, 6528943, 6528944, 6528945, 6528948, 6528949, 6528950, 6528953, 6528956, 6528957, 6528958, 6528959, 6528962, 6528963, 6528965, 6528966, 6528967, 6528968, 6528969, 6528970, 6528971, 6528972, 6528973, 6544814, 6544815, 6544816, 6544817, 6544818, 6544819, 6544820, 6544821, 6544824, 6544825, 6544827, 6544828, 6544829, 6544831, 6544833, 6544834, 6544835, 6544837, 6544838, 6862500, 6862502, 6862506, 6862507, 6862508, 6862509, 6862515, 6862521, 6862528, Z081511); 02-012-38-2511 (10885862178848; 2583871, 2583872, 2583873, 2583874, 2583875, 2583876, 2583877, 2583878, 2974651, 2974652, 2974653, 2974654, 2974655, 2985598, 2985599, 2985601, 2985602, 2985603, 2985605, 2985606, 2985607, 2985608, 2985609, 2985610, 2985612, 2985613, 2985614, 3621124, 3621125, 3621126, 3621127, 3621128, 3621129, 3621130, 3621131, 3621132, 3621133, 3795156, 3826233, 3826235, 3826236, 3826237, 3826238, 3826239, 3875853, 3875854, 3875855, 3875856, 3875857, 3875858, 3875859, 3875860, 3875861, 3875862, 3875863, 3988389, 3988390, 3988391, 3988392, 3988393, 3988394, 3988395, 3988396, 3988397, 3988399, 3988400, 3988401, 3988402, 3988403, 3988404, 3988405, 3988406, 3988407, 3988408, 4046550, 4046551, 4046552, 4046553, 4046554, 4046555, 4046556, 4046557, 4161677, 4161678, 4161679, 4161680, 4161681, 4161682, 4161683, 4161684, 4161685, 4161686, 4161687, 4161688, 4161689, 4161690, 4161691, 4161692, 4161693, 4161694, 4161695, 4161696, 4161697, 4161698, 4161699, 4161700, 4161701, 4161702, 4161703, 4161705, 4161706, 4373527, 4373528, 4373529, 4373530, 4373532, 4373533, 4373534, 4373535, 4373536, 4373537, 4373538, 4373539, 4373540, 4373541, 4373542, 4373544, 4373545, 4373546, 4690336, 4690337, 4690338, 4690339, 4690340, 4690341, 4690342, 4690343, 4690344, 4690345, 4857155, 4857156, 4857157, 4857158, 4857159, 4857160, 4857161, 4857162, 4857163, 4857164, 4881923, 4881924, 4881925, 4881926, 4881927, 4881928, 4881929, 4881930, 4881931, 4881932, 4881933, 4881934, 4881935, 4881936, 4881937, 4881939, 4881940, 4881941, 4881942, 5923138, 5923140, 5923142, 5923143, 5923144, 5923145, 5923146, 5923147, 5923148, 5923150, 5923151, 5923152, 5923154, 5923155, 5923156, 5923159, 5923161, 5923162, 6033287, 6033293, 6033294, 6033295, 6033296, 6033298, 6033300, 6033301, 6033302, 6033303, 6033307, 6033309, 6033312, 6033313, 6033314, 6033315, 6357849, 6357850, 6357851, 6357855, 6357858, 6357860, 6357863, 6357866, 6357867, 6357868, 6357869, 6357872, 6357873, 6357877, 6357878, 6595415, 6595418); 02-012-38-2513 (10885862178855; 2583879, 2583880, 2583882, 2583883, 2583884, 2583885, 2901345, 2901347, 2901348, 2901349, 2901350, 2985892, 2985893, 2985894, 2985895, 2985896, 2985898, 2985899, 2985900, 2985901, 2985902, 2985903, 2985904, 2985906, 2985908, 2985911, 3705278, 3826241, 3826242, 3826243, 3826244, 3826245, 3826246, 3826247, 3826248, 3886035, 3886036, 3886038, 3886039, 3886040, 3886041, 3886042, 3886043, 4046559, 4046560, 4046562, 4046563, 4046564, 4046565, 4365839, 4365840, 4365841, 4365844, 4365851, 4365854, 4365855, 4365856, 4365857, 4365859, 4365863, 4365866, 4365867, 6024439, 6024447, 6024450); 02-012-38-2515 (10885862178862; 2666643, 2666644, 2666647, 2974671, 2985916, 2985917, 2985918, 2985920, 2985921, 2985922, 2985924, 2985925, 2985931, 3795256, 3795257, 3876353, 3876354, 3876355, 4003519, 4175883, 4175884); 02-012-38-3009 (10885862002433; 2112385, 2112386, 2112387, 2112388, 2112389, 2112390, 2112391, 2112392, 2112393, 2112394, 2112395, 2112396, 2112397, 2112398, 2112399, 2112400, 2112401, 2112402, 2112403, 2112404, 2112405, 2112406, 2112407, 2112408, 2112409, 2153492, 2153493, 2153494, 2153495, 2153496, 2153497, 2153498, 2153499, 2153500, 2153501, 2153502, 2153503, 2153504, 2153505, 2153506, 2153507, 2153508, 2153509, 2153510, 2153511, 2153512, 2153513, 2153514, 2153515, 2153516, 2153517, 2153518, 2153519, 2153520, 2243281, 2243282, 2243283, 2243284, 2243285, 2243286, 2243287, 2243288, 2243289, 2256182, 2256183, 2256184, 2256185, 2256186, 2256187, 2256188, 2256189, 2256190, 2288020, 2288021, 2288022, 2288023, 2288024, 2288025, 2288026, 2288027, 2288028, 2288029, 2288030, 2366013, 2366014, 2366015, 2366016, 2366017, 2366018, 2366019, 2366020, 2366021, 2366022, 2366023, 2366024, 2366025, 2366026, 2366027, 2366028, 2366029, 2366030, 2366031, 2366032, 2366033, 2366034, 2366035, 2366036, 2366037, 2366038, 2366039, 2366040, 2366041, 2366042, 2400905, 2400906, 2400907, 2400908, 2400909, 2400911, 2400912, 2400913, 2400914, 2400916, 2400917, 2400918, 2400919, 2400920, 2400921, 2400924, 2400925, 2400926, 2400927, 2400928, 2400929, 2400930, 2400931, 2400932, 2481201, 2481202, 2481203, 2481204, 2481205, 2481206, 2481207, 2481208, 2481209, 2481210, 2481211, 2481212, 2481213, 2481214, 2481216, 2481217, 2481218, 2481219, 2481220, 2481221, 2481222, 2481223, 2481224, 2481225, 2481226, 2481227, 2481228, 2481229, 2550747, 2550748, 2550749, 2550750, 2550751, 2550752, 2550753, 2550754, 2550755, 2550756, 2550757, 2550758, 2550759, 2550760, 2550761, 2550762, 2550763, 2550764, 2550765, 2550766, 2550767, 2550768, 2550769, 2550770, 2550771, 2550772, 2550773, 2550774, 2550775, 2550776, 2659136, 2659137, 2659138, 2659139, 2659140, 2659141, 2659142, 2659143, 2659144, 2659145, 2659146, 2680027, 2680028, 2680029, 2680030, 2680031, 2680032, 2680033, 2680034, 2680035, 2680036, 2708944, 2708945, 2708946, 2724555, 2724556, 2724557, 2724558, 2724559, 2724560, 2724561, 2724562, 2724563, 2724564, 2724565, 2724566, 2724567, 2724568, 2724569, 2724570, 2724571, 2724572, 2784790, 2784791, 2784792, 2784793, 2784794, 2784795, 2784796, 2784797, 2789982, 2789983, 2789984, 2789985, 2789986, 2789987, 2789988, 2789989, 2789990, 2789991, 2789992, 2789993, 2789994, 2789995, 2789996, 2789997, 2789998, 2789999, 2790000, 2790001, 2790002, 2790003, 2790004, 2790005, 2790006, 2790007, 2790008, 2790009, 2790010, 2790011, 2848209, 2848210, 2848211, 2848212, 2848213, 2848214, 2848215, 2848216, 2848217, 2848218, 2848219, 2848220, 2848221, 2848222, 2848223, 2848224, 2848225, 2848226, 2848227, 2848228, 2848229, 2848230, 2848231, 2848232, 2848233, 2848234, 2848235, 2848236,

Distribution pattern

device · product 9 of 9

ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Z-0027-2022

Recall number: Z-0027-2022
Initiated: August 30, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Exactech, Inc.
Quantity: 12 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Code information

Item Number (Device Identifier; Serial number(s)): 256-12-02 (No Device Identifier; 1208624, 1208625, 1208626, 1208627); 256-12-03 (10885862066633; 1208774, 1446326); 256-13-02 (No Device Identifier; 1208710, 1208715); 256-13-03 (No Device Identifier; 1208859, 1208863); 256-13-04 (No Device Identifier; 1209010, 1209013)