GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION ...
FDA Device Recall #Z-1730-2022 — Class II — August 11, 2022
Recall Summary
| Recall Number | Z-1730-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 11, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Exactech, Inc. |
| Location | Gainesville, FL |
| Product Type | Devices |
| Quantity | 2319 devices |
Product Description
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
Reason for Recall
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Distribution Pattern
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN
Lot / Code Information
a. REF 134-28-41, GUDID 10885862023971, Serial Numbers: 1152706, 1152707, 1152709, 1152711, 1152712, 1152713, 1152714, 1152716, 1152717, 1152719, 1152721, 1152722, 1152724, 1152725, 1338587, 1338588, 1338589, 1338590, 1338592, 1338593, 1338594, 1338595, 1338598, 1338599, 1338600, 1338601, 1338602, 1338603, 1338604, 1504513, 1504516, 1514969, 1514972, 1521171, 1521172, 1521173, 1521174, 1521175, 1521176, 1521177, 1521178, 1521179, 1521180, 1521181, 1665721, 1665722, 1665723, 1665724, 1665725, 1665728, 1665730, 1665732, 1665733, 1665734, 1665735, 1665737, 1665738, 1821757, 1821758, 1821759, 1821762, 1821763, 1821764, 1834478, 1834479, 1834480, 1834481, 1834482, 1834483, 1834484, 1834486, 1834487, 1916424, 1916425, 1916426, 1916428, 1916429, 1916430, 1916431, 1916432, 1916433, 1916434, 1916435, 1916436, 1916437, 1916438, 1916439, 1916440, 1916441, 2023328, 2023329, 2023330, 2023331, 2023332, 2023333, 2048938, 2048939, 2049268, 2064326, 2064327, 2064328, 2064329, 2064330, 2064332, 2067222, 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2532608, 2599673, 2599675, 2630871, 2630872, 2630873, 2630874, 2652978, 2652979, 2652980, 2680461, 2680462, 2680463, 2680464, 2680465, 2680466, 2680467, 2680468, 2680469, 2680470, 2680471, 2680473, 2680475, 2680476, 2680477, 2680478, 2680479, 2680480, 2680481, 2680482, 2680483, 2680484, 2680485, 2680486, 2680487, 2736453, 2736454, 2736455, 2736456, 2736457, 2736461, 2736463, 2736465, 2736466, 2736467, 2736469, 2736470, 2736471, 2736472, 2736473, 2736475, 2736476, 2736477, 2736478, 2736479, 2849333, 2849334, 2849335, 2849336, 2849337, 2849338, 2849339, 2849340, 2849341, 2849342, 2849343, 2849344, 2849345, 2849346, 2849347, 2849348, 2849349, 2849350, 2849351, 2849352, 2849353, 2849354, 2849355, 2849356, 2849357, 2849358, 2849359, 2935008, 2935009, 2935011, 2935013, 2935014, 2935015, 2935016, 2935018, 2935019, 2935021, 2935022, 2935023, 2935024, 2935025, 2935026, 2935027, 2935028, 2935029, 2935030, 2935031, 2935032, 2935033, 2935034, 2994514, 2994515, 2994516, 2994517, 2994518, 2994519, 2994520, 2994521, 2994522, 2994523, 2994524, 2994525, 2994526, 2994527, 2994529, 2994530, 2994531, 2994532, 2994533, 2994534, 2994535, 2994536, 3565719, 3565720, 3565721, 3565722, 3565723, 3565724, 3565725, 3565726, 3565727, 3565728, 3565729, 3565730, 3565731, 3565732, 3565733, 3565734, 3565736, 3565737, 3565738, 3565739, 3565740, 3565741, 3565742, 3565743, 3565744, 3648798, 3648799, 3648800, 3648801, 3648802, 3648803, 3648804, 3648805, 3648806, 3648807, 3648808, 3648809, 3648810, 3648811, 3648812, 3648813, 3648814, 3648815, 3648816, 3648817, 3648818, 3648819, 3648820, 3648821, 3648822, 3648823, 3715438, 3715439, 3715440, 3715441, 3715442, 3715443, 3715444, 3715445, 3715447, 3715448, 3715449, 3715451, 3715452, 3715453, 3715454, 3715455, 3799127, 3799128, 3799129, 3799130, 3799131, 3799132, 3799133, 3799134, 3799135, 3799136, 3799137, 3799138, 3799139, 3799140, 3799141, 3799142, 3799144, 3799145, 3799146, 4121670, 4121671, 4121672, 4121673, 4121674, 4121675, 4121676, 4121678, 4121679, 4121681, 4121682, 4121683, 4121684, 4121686, 4121687, 4121688, 4121689, 4201717, 4201718, 4201720, 4201721, 4201722, 4201723, 4201725, 4201727, 4201728, 4201729, 4201730, 4201731, 4201732, 4201733, 4201735, 4201736, 4221082, 4221084, 4221085, 4221086, 4221087, 4221088, 4221089, 4221090, 4221091, 4260045, 4260046, 4260047, 4260048, 4260049, 4260050, 4260051, 4260052, 4260054, 4260055, 4260056, 4260058, 4495979, 4495980, 4495981, 4495982, 4495983, 4495985, 4495986, 4495988, 4495989, 4495990, 4495991, 4495992, 4495993, 4495994, 4495995, 4495996, 4495997, 4495998, 4495999, 4496003, 4625465, 4625466, 4625467, 4625468, 4625469, 4625470, 4625471, 4625472, 4625473, 4625474, 4625475, 4625476, 4625477, 4625478, 4625479, 4625480, 4625481, 4625482, 4625483, 4625484, 4801052, 4801054, 4801055, 4801056, 4801057, 4801058, 4801059, 4801061, 4861232, 4861233, 4861234, 4861235, 4861236, 4861237, 4861238, 4861239, 4861240, 4886427, 4886429, 4886430, 4886431, 4886432, 4886433, 4886434, 4886435, 4886436, 4886437, 4886439, 4886440, 4886441, 4886443, 4886444, 4886445, 4886446, 4886447, 4886448, 4886449, 4886450, 4886451, 4886452, 5128950, 5128951, 5128952, 5128953, 5128954, 5128955, 5128956, 5128957, 5128958, 5128959, 5175908, 5175909, 5175910, 5175911, 5175912, 5175913, 5175914, 5175915, 5175917, 5335272, 5335273, 5335274, 5335275, 5335276, 5335277, 5335278, 5335279, 5335280, 5335282, 5335283, 5335284, 5335285, 5335286, 5335287, 5335288, 5335289, 5335290, 5335291, 5335292, 5335293, 5335294, 5335295, 5335296, 5335297, 5335299, 5335300, 5440692, 5440693, 5440694, 5440695, 5440696, 5440697, 5440698, 5440700, 5440702, 5440703, 5440704, 5504861, 5504863, 5504864, 5504865, 5504867, 5504868, 5504869, 5504870, 5504872, 5594159, 5594160, 5594161, 5594162, 5594163, 5594164, 5594165, 5594166, 5594167, 5594169, 5594170, 5641743, 5641744, 5641746, 5641747, 5641748, 5641749, 5641752, 5641754, 5641755, 5641756, 5735870, 5735871, 5735872, 5735873, 5735874, 5735875, 5735876, 5735877, 5735878, 5735879, 5735880, 5735881, 5735882, 5735883, 5735884, 5735885, 5735887, 5735888, 5735889, 5877059, 5877060, 5877061, 5877062, 5877063, 5877064, 5877065, 6087471, 6087472, 6087473, 6087474, 6087475, 6087478, 6087480, 6087481, 6087482, 6087483, 6087484, 6087485, 6087486, 6087489, 6087490, 6087492, 6087493, 6087496, 6087497, 6087498, 6087500, 6141332, 6141333, 6141334, 6141335, 6141336, 6141337, 6141338, 6141339, 6141341, 6141342, 6141345, 6141346, 6141347, 6141348, 6141349, 7050778, 7050779, 7050780, 7050781, 7050782, 7050783, 7050785, 7050786, 7050787, 7092261, 7092262, 7092263, 7092268, 7092270, 7092271, 7092272, 7092273, 7092277; b. REF 134-32-42, GUDID 10885862023988, Serial Numbers: 1152933, 1152935, 1152936, 1152937, 1152938, 1152939, 1152940, 1152941, 1152942, 1152943, 1152944, 1152945, 1152946, 1152947, 1152948, 1152949, 1152950, 1332353, 1332354, 1332355, 1332356, 1332357, 1332358, 1332359, 1332360, 1332361, 1332362, 1332363, 1332364, 1332366, 1332367, 1332368, 1332370, 1332371, 1332372, 1363147, 1363148, 1363150, 1363151, 1363154, 1363156, 1363157, 1363158, 1363159, 1363160, 1363162, 1363163, 1363165, 1363166, 1499570, 1499571, 1499572, 1499575, 1517160, 1517162, 1517163, 1517164, 1517165, 1517166, 1589904, 1589905, 1589906, 1589907, 1589908, 1589909, 1589911, 1589912, 1589914, 1589916, 1589918, 1589920, 1589921, 1589922, 1589923, 1589927, 1589928, 1589929, 1589930, 1589931, 1589933, 1589934, 1589935, 1641526, 1641529, 1641530, 1641531, 1641533, 1641534, 1641535, 1641536, 1641537, 1641540, 1653119, 1653120, 1653122, 1653123, 1653124, 1653125, 1653127, 1653128, 1653130, 1820709, 1820710, 1820711, 1820712, 1820714, 1820715, 1820717, 1820718, 1820719, 1906327, 1906328, 1906329, 1906330, 1906331, 1906332, 1906333, 1906334, 1906335, 1906336, 1906338, 1924469, 1924470, 1924471, 1924472, 1924473, 1948966, 1948967, 1948968, 1948969, 1948970, 1948973, 1948974, 1948976, 1948977, 1948978, 1948979, 1948980, 1948981, 1948982, 1948983, 1948984, 1948985, 1948986, 2045947, 2045948, 2045950, 2045951, 2045952, 2045953, 2045954, 2045955, 2045956, 2045957, 2045958, 2045960, 2045961, 2045962, 2045963, 2045964, 2045965, 2045966, 2045967, 2045968, 2045969, 2045970, 2045971, 2045972, 2045973, 2045974, 2045975, 2045976, 2045977, 2045978, 2045979, 2092737, 2092738, 2092739, 2092740, 2092741, 2092742, 2092744, 2092746, 2092747, 2092748, 2150963, 2150964, 2150965, 2150966, 2150967, 2150968, 2150969, 2150970, 2150971, 2150972, 2167964, 2167965, 2167966, 2167967, 2167968, 2167969, 2167970, 2167971, 2167972, 2167973, 2167974, 2167975, 2167976, 2167977, 2167978, 2167979, 2167980, 2167981, 2167982, 2200417, 2200418, 2200419, 2200420, 2200421, 2200422, 2200423, 2200424, 2200425, 2200426, 2200428, 2200429, 2200430, 2200431, 2200432, 2200433, 2200434, 2239735, 2239736, 2239737, 2239738, 2239739, 2239740, 2239741, 2239742, 2278207, 2278209, 2278210, 2278211, 2278212, 2278213, 2278214, 2278215, 2278216, 2278217, 2278218, 2278219, 2324604, 2324605, 2324606, 2324607, 2324608, 2324609, 2324610, 2324611, 2324612, 2324614, 2324615, 2324616, 2381423, 2381424, 2381425, 2381426, 2381428, 2381429, 2381430, 2381431, 2381432, 2381433, 2381434, 2381435, 2381436, 2381437, 2381438, 2381439, 2381440, 2381441, 2381442, 2381443, 2381444, 2381445, 2381446, 2381447, 2381448, 2436991, 2436992, 2436993, 2436994, 2436995, 2436996, 2436997, 2436998, 2436999, 2437000, 2437001, 2437002, 2437003, 2437004, 2437005, 2437006, 2437007, 2437008, 2437009, 2437010, 2534578, 2534579, 2534581, 2534582, 2534583, 2534586, 2534587, 2534588, 2534589, 2534590, 2534591, 2534592, 2534594, 2576261, 2576262, 2576263, 2576264, 2576265, 2576266, 2576267, 2666487, 2666488, 2666489, 2666490, 2666491, 2666492, 2666493, 2666494, 2666496, 2666497, 2666498, 2666499, 2666500, 2666501, 2666502, 2666503, 2666504, 2666505, 2666506, 2666507, 2666508, 2666509, 2666511, 2666512, 2666513, 2775409, 2775410, 2775411, 2775412, 2775413, 2775414, 2775415, 2775416, 2775418, 2775420, 2775421, 2775422, 2878263, 2878264, 2878265, 2878266, 2878267, 2878268, 2878269, 2878270, 2878271, 2878272, 2878273, 2916962, 2916963, 2916964, 2916966, 2916967, 2916968, 2916969, 2916971, 2916972, 2916973, 2916974, 2916975, 2916976, 2916977, 2916978, 2976255, 2976256, 2976257, 2976258, 2976259, 2976260, 2976261, 2998473, 2998474, 2998475, 2998476, 2998477, 2998478, 2998479, 2998480, 2998481, 2998482, 2998484, 2998485, 2998486, 2998487, 2998488, 2998489, 2998490, 2998492, 2998493, 2998494, 2998495, 3631526, 3631527, 3631528, 3631529, 3631530, 3631531, 3631532, 3631533, 3631534, 3631535, 3631536, 3631537, 3631538, 3631539, 3631540, 3631541, 3631542, 3631543, 3631544, 3631545, 3631546, 3631547, 3631548, 3631549, 3631550, 3662940, 3662941, 3662942, 3662943, 3662944, 3662945, 3662946, 3662947, 3662948, 3662949, 3662950, 3662951, 3662952, 3662953, 3662954, 3662955, 3662956, 3685937, 3685938, 3685939, 3685940, 3685942, 3685943, 3685944, 3685945, 3685947, 3685948, 3685950, 3685953, 3685954, 3685955, 3685956, 3687468, 3687469, 3687470, 3687471, 3687472, 3687473, 3799032, 3799034, 3799035, 3799037, 3799038, 3799041, 3799042, 3799043, 3799046, 3799047, 3799048, 3799049, 3799050, 3799051, 3894443, 3894444, 3894445, 3894446, 3894447, 3894448, 3894449, 3894450, 3894451, 3894452, 3894453, 3894454, 3894455, 3894456, 3894457, 3894458, 3894459, 3894460, 3894461, 3894462, 3894463, 3894464, 3894465, 4111024, 4111025, 4111026, 4111027, 4111028, 4111029, 4111030, 4111031, 4111032, 4111033, 4111034, 4111035, 4111036, 4111037, 4111038, 4111039, 4111040, 4111041, 4111042, 4111043, 4111044, 4111045, 4111046, 4201697, 4201698, 4201699, 4201700, 4201701, 4201702, 4201703, 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4861398, 4861399, 4861400, 4861401, 4861402, 4861403, 4861404, 4861405, 4861406, 4992726, 4992727, 4992728, 4992731, 4992733, 4992734, 4992735, 5140346, 5140347, 5140348, 5140349, 5140350, 5140351, 5140353, 5140354, 5140355, 5171907, 5171908, 5171909, 5171910, 5171911, 5171912, 5171913, 5171914, 5171915, 5171916, 5171917, 5171918, 5171919, 5171920, 5171921, 5171923, 5171924, 5171925, 5171927, 5171928, 5171929, 5171931, 5171932, 5356657, 5356658, 5356660, 5356661, 5356662, 5356663, 5356665, 5356666, 5356667, 5479538, 5479539, 5479540, 5479541, 5479542, 5479543, 5479544, 5479545, 5479546, 5479547, 5479548, 5479549, 5479550, 5479551, 5479553, 5479554, 5479555, 5479556, 5479557, 5479558, 5479559, 5479560, 5479561, 5479562, 5550272, 5550273, 5550274, 5550275, 5550276, 5550277, 5550278, 5550279, 5550280, 5550281, 5550282, 5550283, 5550284, 5550285, 5550286, 5550287, 5550288, 5550289, 5550294, 5550295, 5550296, 5550297, 5550298, 5630398, 5630400, 5630401, 5630402, 5630403, 5630404, 5630405, 5630407, 5630409, 5630410, 5630411, 5630412, 5630413, 5630414, 5630415, 5630416, 5630418, 5630419, 5630420, 5630421, 5630422, 5630423, 5992114, 5992115, 5992116, 5992118, 5992119, 5992120, 5992121, 5992122, 5992123, 5992125, 5992127, 5992128, 5992129, 5992130, 5992132, 5992134, 5992135, 5992138, 5992140, 5992141, 6638943, 6638944, 6638945, 6638946, 6638947, 6638948, 6638950, 6638951, 6638952, 6638954, 6638955, 6638956, 6638957, 6638959, 6638960, 6638961, 6638962, 6638966, 6638969, 7031973, 7031974, 7092067, 7092068, 7092071, 7092072, 7092073, 7092075, 7092076, 7092081, 7092082, 7092084, 7092085; c. REF 134-36-43, GUDID 10885862024022, Serial Numbers: 1152913, 1152914, 1152915, 1152916, 1152917, 1152918, 1152919, 1152921, 1152922, 1152923, 1152926, 1152927, 1152928, 1152929, 1152931, 1152932, 1334413, 1334414, 1334415, 1334416, 1334417, 1334418, 1334420, 1334421, 1334423, 1334424, 1334425, 1334427, 1334430, 1334432, 1396299, 1396301, 1396302, 1396303, 1396304, 1396305, 1396307, 1396309, 1396310, 1396312, 1396313, 1396314, 1396317, 1396318, 1396319, 1521910, 1521912, 1521913, 1521914, 1521916, 1521917, 1521918, 1521919, 1521920, 1521921, 1521922, 1605519, 1605520, 1605521, 1605522, 1605523, 1605524, 1605526, 1605527, 1655022, 1655024, 1655026, 1655028, 1655029, 1655030, 1655032, 1655033, 1655034, 1655035, 1655036, 1655037, 1655038, 1655039, 1655040, 1655041, 1655042, 1893502, 1893503, 1893504, 1893507, 1893508, 1893510, 1893512, 1893513, 1893514, 1893515, 1946913, 1946914, 1946915, 1946916, 1946917, 1987580, 1987581, 1987582, 1987583, 1987584, 1987585, 1987586, 1987587, 1987589, 1987590, 1987591, 1987592, 1987593, 1987594, 1987595, 1987596, 1987597, 1987598, 1987599, 1987600, 2005863, 2005864, 2005865, 2005866, 2005869, 2005870, 2005871, 2090722, 2090724, 2090725, 2090727, 2090728, 2090729, 2090731, 2090732, 2090733, 2090734, 2090735, 2090736, 2090737, 2168380, 2168381, 2168382, 2168383, 2168384, 2168385, 2168386, 2168387, 2168388, 2168389, 2168390, 2168391, 2168392, 2168393, 2168394, 2168396, 2168397, 2168398, 2168399, 2168400, 2168401, 2168402, 2168403, 2168404, 2168405, 2168406, 2168407, 2168408, 2168409, 2168410, 2375660, 2375662, 2375663, 2375664, 2375665, 2375666, 2375667, 2375668, 2375669, 2375670, 2375671, 2375672, 2375673, 2375674, 2375675, 2426888, 2426889, 2426890, 2426891, 2426892, 2426893, 2426894, 2426895, 2426896, 2426897, 2426899, 2426900, 2426901, 2426902, 2426903, 2426904, 2426905, 2426906, 2426907, 2426908, 2484250, 2484251, 2484252, 2484254, 2484255, 2484256, 2484259, 2484260, 2484261, 2484262, 2484263, 2484264, 2484265, 2484266, 2484267, 2484268, 2484269, 2484270, 2484271, 2484272, 2484273, 2484274, 2576270, 2576271, 2709176, 2778634, 2778635, 2778638, 2801748, 2801749, 2878178, 2878179, 2878180, 2878181, 2878182, 2878183, 2878184, 2878185, 2878186, 2878187, 2878188, 2980075, 2980076, 2980077, 2980078, 2980079, 2980081, 2980082, 2980084, 2980085, 2980086, 2980087, 2980088, 2980090, 2980091, 2980092, 2980093, 2980094, 2980095, 2980096, 2980097, 2980098, 2980099, 2980100, 3601763, 3601764, 3601765, 3601766, 3601767, 3601768, 3601769, 3601770, 3601771, 3601772, 3601773, 3601774, 3601775, 3601776, 3601777, 3601778, 3601779, 3601780, 3601781, 3601782, 3601783, 3601786, 3601787, 3692265, 3692266, 3692267, 3692268, 3692270, 3692271, 3692272, 3692273, 3692274, 3692275, 3692276, 3692277, 3692279, 3692280, 3692281, 3692282, 3692283, 3692284, 3778039, 3841749, 3841750, 3841751, 3841752, 3874856, 3874857, 3874858, 3874859, 3874860, 3874861, 3874862, 3874863, 3892593, 3892594, 3892595, 4045479, 4045480, 4045481, 4045482, 4045483, 4045484, 4045485, 4045486, 4045487, 4045488, 4045489, 4117302, 4117303, 4117304, 4117305, 4117306, 4117307, 4117308, 4117309, 4117312, 4117313, 4117316, 4117319, 4117323, 4117326, 4117327, 4384073, 4384074, 4384076, 4384077, 4384083, 4384085, 4384086, 4384087, 4384089, 4384091, 4384092, 4384093, 4384094, 4384095, 4384096, 4748152, 4748153, 4854767, 4854768, 4854769, 4854770, 4854771, 4854772, 4854773, 4854774, 4854775, 4854776, 4854777, 4854778, 4854779, 4854780, 4854781, 4854782, 4854783, 4854784, 4854785, 5002352, 5002353, 5002354, 5002356, 5002358, 5002359, 5002360, 5027374, 5027375, 5027376, 5027377, 5027378, 5027379, 5027380, 5027381, 5027382, 5027383, 5087825, 5087828, 5087829, 5087830, 5087831, 5087832, 5087833, 5087834, 5159603, 5159604, 5159605, 5159606, 5159608, 5159609, 5159610, 5159611, 5505042, 5505043, 5505046, 5505047, 5505048, 5505049, 5505050, 5505052, 5505053, 5505054, 5505055, 5505056, 5505057, 5505058, 5505060, 5505061, 5505062, 5505063, 5505065, 5505067, 5505068, 5505069, 5700295, 5700297, 5700298, 5700300, 5700304, 5700305, 5700306, 5700308, 5700309, 5700313, 6135317, 6135318, 6135319, 6135320, 6135324, 6135326, 6135328, 6135330, 6135332, 6135333, 6135339, 6135340, 6135341, 6135342, 6136243, 6136245, 6136246, 6136250, 6136251, 6136252, 6136254, 6136256, 6136258, 6136261, 6136264, 6136266, 6136267, 6136268; d. REF 134-36-44, GUDID 10885862024039, Serial Numbers: 1152727, 1152728, 1152729, 1152730, 1152731, 1152732, 1152735, 1152736, 1152737, 1152739, 1152740, 1152742, 1152745, 1152746, 1338518, 1338519, 1338520, 1338522, 1338523, 1338524, 1338525, 1338526, 1338527, 1338530, 1338531, 1338532, 1338533, 1338534, 1338535, 1338536, 1338537, 1338538, 1516138, 1520744, 1520745, 1520749, 1520750, 1520751, 1520754, 1793730, 1793731, 1793732, 1793734, 1793735, 1793736, 1822158, 1822159, 1822160, 1822161, 1822162, 1822163, 1822166, 1844081, 1844083, 1844085, 1844086, 1844087, 1844088, 1844089, 1924327, 1924328, 1924331, 1924332, 1924333, 1924334, 1924335, 2078533, 2078534, 2152495, 2152496, 2152497, 2155194, 2155196, 2155197, 2155198, 2155200, 2155202, 2155204, 2155205, 2155206, 2155207, 2191334, 2191335, 2191336, 2191338, 2191339, 2191340, 2191341, 2191342, 2191343, 2191344, 2191346, 2407773, 2407774, 2407775, 2407776, 2407777, 2407778, 2407779, 2407780, 2481273, 2481274, 2481276, 2481278, 2481279, 2481281, 2481282, 2576273, 2594884, 2594885, 2594887, 2594891, 2594895, 2594896, 2594897, 2594898, 2594899, 2594900, 2594901, 2594902, 2594903, 2594904, 2594906, 2594907, 2594910, 2594913, 2594916, 2594917, 2594918, 2594920, 2986035, 2986036, 2986038, 2986039, 2986040, 2986041, 2986043, 2986044, 2986045, 2986046, 2986048, 2986049, 2986050, 2986051, 2986052, 2986053, 2986054, 2986056, 2986057, 2986059, 2986060, 2986061, 3683430, 3683432, 3683433, 3683435, 3683437, 3683438, 3683440, 3683441, 3683442, 3683443, 3683444, 3683445, 3683446, 3683447, 4076513, 4076514, 4076515, 4076517, 4076518, 4076519, 4076521, 4076522, 4076525, 4076530, 4076531, 4076534, 4076535, 4076538, 4076539, 4076540, 4215024, 4215025, 4215027, 4215035, 4751282, 4751283, 4751284, 4751285, 4751286, 4861627, 4861629, 4861632, 4861634, 5272148, 5272149, 5272152, 5303301, 5303303, 5381552, 5381558, 5381560, 5580111, 5580112, 5580113, 5580114, 5580115, 5866595, 5866597, 5866598, 6259942, 6259945, 6498857, 6498860, 6498861, 6498864, 6498865; e. REF 134-36-45, GUDID 10885862024046, Serial Numbers: 1152771, 1152772, 1152773, 1152778, 1152779, 1152780, 1152782, 1152784, 1338607, 1338608, 1338616, 1338617, 1338621, 1338624, 1338626, 1522159, 1522160, 1522162, 1641855, 1641858, 1641860, 1641864, 1641865, 1641867, 1641868, 1641869, 2006195, 2006196, 2006197, 2010909, 2010911, 2010913, 2010915, 2010920, 2010921, 2481293, 2677743, 2778776, 2800313, 2976244, 2976245, 2976246, 2976247, 2976248, 2976249, 2976251, 2976252, 2976253, 3768216, 3768219, 3768225, 3768229, 4137300, 4137314, 4137316, 4622463;
Other Recalls from Exactech, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1509-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Ergo M... | Feb 3, 2026 |
| Z-1510-2026 | Class II | Brand Name: Equinoxe Product Name: Equinoxe C... | Feb 3, 2026 |
| Z-0536-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Adjust... | Sep 5, 2025 |
| Z-0537-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Ergo A... | Sep 5, 2025 |
| Z-0535-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Adjust... | Sep 5, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.