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Novation recallZ-1730-2022 · Exactech, Inc. · initiated Aug 11, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

FDA root cause category: Process control

What the company is doing

The firm sent an "URGENT MEDICAL DEVICE RECALL" DEAR HEALTHCARE PROFESSIONAL COMMUNICATION on 08/11/2022 by email. The purpose of the current letter is to update surgeons regarding the implications of the packaging non-conformity on performance of the Connexion GXL and other conventional UHMWPE acetabular liners. In addition, this letter provides updates to patient management and follow-up recommendations since issuance of the July 2021 DHCP letter. In addition to providing surgeons with lists of all their affected GXL and/or conventional polyethylene patients since 2004, Exactech is providing surgeons with two draft letters directed at patients who have been implanted with Exactech GXL hip devices. The Customers were instructed to take the following actions: CAREFULLY REVIEW THIS RECALL NOTIFICATION to ensure that you fully understand the issue identified, the recall strategy, and all actions required. IMMEDIATELY IDENTIFY AND QUARANTINE any of the subject devices in your inventory and/or customers inventory. EXTEND THE DESCRIPTION OF THE ISSUE AND CLINICAL IMPACT as described in the recall notification to your accounts that may have this product in their possession. COMPLETE AND RETURN the attached Recall Inventory Response Form to Exactech via email at [email protected]. Reach out to Customer Service at [email protected] to request a Returned Goods (RG) Number for ALL affected product requested to be returned. WE ARE REQUIRING 100% EFFECTIVENESS FOR THIS RECALL. If you have any questions, call (888) 912-0403.

Recall details

Recall number
Z-1730-2022
Status
Open, Classified
Initiated by the company
Aug 11, 2022
Recalling firm
Exactech, Inc.
Quantity
2319 devices
Product code
KWZ
FDA submissions
K071676
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN

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

Code information (models, lots, serial numbers)

Show the full code information (21k characters)

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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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, 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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;

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K071676 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 90279).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page