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U.S. Department of Health and Human Services

Class 2 Device Recall OPTETRAK Comprehensive Knee System

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  Class 2 Device Recall OPTETRAK Comprehensive Knee System see related information
Date Initiated by Firm August 30, 2021
Date Posted October 04, 2021
Recall Status1 Open3, Classified
Recall Number Z-0026-2022
Recall Event ID 88570
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product 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.
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, 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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, 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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, 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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, 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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, 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4905508, 4905511, 4905512, 4905513, 4905515, 5029507, 5029508, 5029509, 5029510, 5335882, 5335883, 5335885, 5335886, 5335887, 5335890, 5335894, 5466468, 5466469, 5717681, 5717682, 5717683, 5717688, 5717689, 5903171, 5903180, 5903181, 5903182, 5905863, 5905866, 5905867, 5905875, 5905876, 5905879, 5905881, 5905883, 5905884, 6595763); 02-012-38-5013 (10885862002532; 2112905, 2112907, 2112908, 2112909, 2112913, 2112914, 2112916, 2112917, 2112919, 2112922, 2112924, 2112925, 2112926, 2112932, 2112933, 2112934, 2381268, 2381269, 2381270, 2381271, 2381272, 2381274, 2381277, 2381280, 2381281, 2901600, 2901602, 2901605, 2901607, 2901609, 3636425, 3636428, 3636429, 3695826, 3795229, 3811385, 3811387, 3811389, 3879328, 3879329, 3964784, 3964785, 3989350, 4081289, 4081290, 4205645, 4205647, 4205654, 4205658, 4562008, 5435657, 5981023, 6105443, 6105446); 02-012-38-5015 (10885862002549; 2113244, 2113252, 2113258, 2113267, 2113268, 2113269, 2675194, 2778381, 2901612, 2901613, 2901616, 2901620, 3626233, 3626234, 3626235, 3795160, 3989328, 3989329, 3989331, 4016559, 4114325, 4311348, 4311352)
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Nicholas Bennett
800-392-2832
Manufacturer Reason
for Recall		 Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
FDA Determined
Cause 2		 Process control
Action Exactech notified distributors and sales representatives on about 08/30/2021 via letter titled "URGENT MEDICAL DEVICE RECALL." Actions included removing all Knee and Ankle UHMWPE products labeled with an 8-year shelf life and not packaged in EVOH/Nylon bags, in a phased approach over 12 months. Phase 1: immediately return all knee and ankle UHMWPE devices labeled with an 8-year shelf life that will be 5 years old or older by 08/31/2022 not packaged in EVOH/Nylon bags. Phase 2: between 05/31/2022 to 08/31/2022, returning all remaining knee and ankle UHMWPE devices labeled with an 8-year shelf life not packaged in EVOH/Nylon bags. A communication to healthcare professionals should follow. Instructions to recipients included to immediately identify and quarantine any affected product in inventory, notify customers down the line if further distributed, and complete and return the Recall Inventory Response Form to Exactech via email at recalls@exac.com. Exactech expanded their recall and sent an updated notification to US agents and distributors on 02/07/2022. On about 02/08/2022, a letter to surgeons and hospitals was sent. The notifications indicated that all non-conforming devices were included in the recall, to cease use of those devices, and work with sales agents to return any inventory. The letters to surgeons and hospitals also advised physicians regarding follow up with implanted patients.
Quantity in Commerce 8,985 devices
Distribution Worldwide distribution - US Nationwide distribution and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, ECUADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GHANA, GREAT BRITAIN, GREECE, GUATEMALA, INDIA, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, ROMANIA, SINGAPORE, SPAIN, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TUNISIA, TURKEY, VENEZUELA .
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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