Class 2 Device Recall Exactech

• Date Initiated by Firm: August 11, 2022
• Create Date: September 09, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1731-2022
• Recall Event ID: 90279
• 510(K)Number: K100269
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: ; a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; ; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; ; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; ; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70
• Code Information: a. 130-28-50, GUDID 10885862022059, Serial Numbers: 1784995, 1784996, 1784998, 1785000, 1785002, 1785003, 1785006, 1785011, 1785012, 1785013, 1785015, 1785016, 1785017, 1785018, 1785022, 1785024, 1785026, 1785027, 1785030, 1785032, 1785033, 1796637, 1796640, 1796641, 1796642, 1796644, 1796647, 1796652, 1796654, 1796655, 1796656, 1796658, 1810811, 1810813, 1810814, 1810818, 1810819, 1810821, 1810822, 1810825, 1810828, 1810829, 1810831, 1810832, 1859562, 2540144, 2540145, 2540146, 2540147, 2540148, 2540150, 2633432, 2633433, 2691744, 2691746, 2691747, 2691748, 2691749, 2691750, 2691751, 2691752, 2707045, 2707047, 2707048, 2707049, 2707050, 2800307, 2800308, 2812276, 2812277, 2893670, 2893671, 2893672, 2976865, 2976866, 2976867, 2976868, 2976869, 3544420, 3544421, 3544422, 3544423, 3544424, 3544431, 3544432, 3544435, 3544437, 3544439, 3544442, 3544444, 3544445, 3544446, 3544447, 3544450, 3673569, 3673571, 3673572, 3673573, 3673574, 3673575, 3673577, 3673578, 3673579, 3673581, 3673583, 3673586, 3673587, 3673588, 3673589, 3673592, 3673593, 3673594, 3673595, 3673596, 3673597, 3673598, 3673599, 3673600, 3712228, 3712229, 3712230, 3712231, 3712232, 3712234, 3712236, 3712238, 3712239, 3712241, 3712455, 3712457, 3712458, 3712459, 3712460, 3712462, 3712463, 3744701, 3744702, 3744703, 3744704, 3744705, 3744706, 3744707, 3744708, 3744710, 3744713, 3744714, 3744715, 3744716, 3744717, 3744718, 3744720, 3744722, 3744723, 3744724, 3978806, 3978807, 3978808, 3978810, 3978811, 3978815, 3978817, 3978818, 3978819, 3978820, 3978822, 3978823, 3978824, 3978825, 4142832, 4142836, 4142837, 4142838, 4142842, 4142845, 4142846, 4142847, 4142848, 4142851, 4142854, 4383613, 4383614, 4383615, 4383617, 4383618, 4383620, 4383622, 4383623, 4383624, 4383625, 4383626, 4383628, 4383629, 4383630, 4383631, 4383632, 4383633, 4383634, 4383635, 4383637, 4383638, 4383639, 4478739, 4478740, 4478741, 4478742, 4478743, 4478744, 4478746, 4478747, 4478750, 4478753, 4478754, 4478756, 4478757, 4478758, 4478762, 4478763, 4478764, 4673689, 4673690, 4673692, 4673693, 4673694, 4673695, 4673696, 4673699, 4673700, 4673701, 4699019, 4699020, 4699021, 4699022, 4699023, 4727112, 4727113, 4727114, 4727115, 4727116, 4727117, 4770113, 4770116, 4770117, 4770118, 4770119, 4770120, 4770121, 4770122, 4788829, 4788830, 4788831, 4788832, 4788833, 4788835, 4788836, 4788838, 4813711, 4813712, 4813713, 4813716, 4836757, 4836758, 4836759, 4836760, 4836761, 4836762, 4836763, 4836764, 4836765, 4836766, 4836767, 4836768, 4836769, 4836770, 4836771, 4836773, 4845642, 4845643, 4845644, 4845645, 4845646, 4845647, 4845648, 4845649, 4845650, 4845651, 4845652, 4845653, 4845654, 4845655, 4845656, 4845657, 5027363, 5027364, 5027365, 5027366, 5027367, 5027368, 5027369, 5027371, 5027372, 5092203, 5092207, 5092209, 5092210, 5092211, 5092212, 5133514, 5133515, 5133516, 5133517, 5133518, 5133519, 5133520, 5133521, 5133522, 5133523, 5138402, 5138403, 5138405, 5138406, 5138407, 5138408, 5138409, 5138411, 5192509, 5192510, 5192511, 5192512, 5192513, 5192514, 5192515, 5192518, 5265341, 5265343, 5265346, 5265347, 5265349, 5265350, 5265356, 5265357, 5265359, 5265360, 5265361, 5265362, 5265364, 5469670, 5469671, 5469672, 5469674, 5469677, 5469678, 5469681, 5469682, 5469684, 5469685, 5469687, 5469688, 5525315, 5525316, 5525317, 5525318, 5525319, 5525320, 5525321, 5556531, 5556532, 5556533, 5556534, 5556536, 5556537, 5556539, 5556540, 5556543, 5556544, 5556546, 5556547, 5556550, 5556551, 5556553, 5768901, 5768903, 5768906, 5768908, 5768911, 5768912, 5768915, 5768917, 5768918, 5768919, 5768923, 5768924, 5921794, 5921796, 5921798, 5921802, 5921804, 5921805, 5921807, 5921811, 5921815, 5921816, 5921817, 5921819, 6664657; b. 130-22-70, GUDID 10885862021892, Serial Numbers: 1787743, 1787757, 1787758, 1787764, 2827594, 2827595, 2827596, 2827597, 2827598, 2827599, 2827600, 2827601, 2827602, 2827603, 2827604, 2827605, 2827606, 2827607, 2827608, 2827609, 2827610, 2900032; c. 132-28-50, GUDID 10885862023148, Serial Numbers: 1785082, 1785083, 1785084, 1785088, 1785089, 1785091, 1785092, 1785096, 1785097, 1785098, 1785099, 1785100, 1785101, 1785106, 1785108, 1785110, 1785115, 1785117, 1785119, 1785120, 1785121, 1785122, 1785123, 1797031, 1797032, 1797033, 1797034, 1797035, 1797039, 1797041, 1797042, 1797043, 1797046, 1797047, 1797050, 1811551, 1811552, 1811553, 1811554, 1811556, 1811557, 1811559, 1811560, 1811561, 1811563, 1811564, 1811565, 1811566, 1811567, 1811568, 1811569, 1852506, 1852507, 1852508, 1852509, 1852512, 1852513, 1852515, 1852516, 1852517, 1852518, 1852519, 1852520, 1870759, 1870760, 1870761, 1870762, 1870764, 1870765, 1870766, 1870767, 1870768, 1870769, 1870770, 2133603, 2133604, 2133605, 2133606, 2133607, 2133608, 2133609, 2133610, 2133611, 2133612, 2133613, 2133614, 2133615, 2133616, 2133617, 2133618, 2133619, 2133620, 2133621, 2133622, 2133624, 2133625, 2133626, 2133627, 2133629, 2133630, 2158036, 2158037, 2158038, 2158039, 2158040, 2158041, 2158042, 2158043, 2158044, 2158046, 2158047, 2158048, 2158049, 2158050, 2158051, 2158052, 2186820, 2186822, 2186823, 2186824, 2186825, 2186826, 2186827, 2186828, 2186829, 2193170, 2193171, 2193172, 2193173, 2193175, 2193176, 2193177, 2193178, 2193180, 2193181, 2193182, 2193183, 2193184, 2225603, 2225604, 2225605, 2225606, 2225607, 2225608, 2225609, 2225610, 2225611, 2225612, 2225613, 2225614, 2225615, 2225617, 2225618, 2225619, 2225620, 2225621, 2225622, 2225623, 2225624, 2225625, 2225627, 2225628, 2225629, 2225630, 2229568, 2229569, 2229570, 2229571, 2229572, 2275710, 2275712, 2275714, 2275715, 2275716, 2275719, 2275720, 2275722, 2275723, 2275724, 2275725, 2275726, 2275727, 2275728, 2275729, 2275730, 2275731, 2275733, 2275734, 2275735, 2319138, 2319139, 2319140, 2319142, 2319143, 2319144, 2319145, 2319146, 2319147, 2322304, 2322305, 2322306, 2322307, 2322308, 2322309, 2322310, 2322311, 2322312, 2322313, 2322314, 2322315, 2322316, 2322317, 2322318, 2322319, 2322320, 2322321, 2322322, 2322323, 2322324, 2322325, 2322326, 2322327, 2322329, 2322330, 2322331, 2322332, 2322333, 2359990, 2359991, 2359992, 2359993, 2359994, 2359995, 2359996, 2359997, 2359998, 2359999, 2360000, 2360001, 2360002, 2360003, 2360004, 2360005, 2360006, 2360007, 2360008, 2360009, 2360010, 2360011, 2360012, 2360013, 2360014, 2360015, 2360016, 2360017, 2360018, 2360019, 2360020, 2360021, 2432540, 2432541, 2432542, 2432543, 2432544, 2432545, 2432546, 2432547, 2432548, 2432550, 2432552, 2432553, 2432554, 2432555, 2432556, 2432557, 2432558, 2432559, 2432560, 2432561, 2432562, 2432563, 2432564, 2471859, 2471860, 2471861, 2471862, 2471863, 2471864, 2471865, 2471866, 2471867, 2471868, 2471869, 2471870, 2471871, 2471872, 2471873, 2471874, 2471875, 2471876, 2471877, 2471878, 2471879, 2471880, 2471881, 2471882, 2471883, 2471884, 2479899, 2479900, 2479901, 2479902, 2479903, 2479904, 2479905, 2479906, 2479907, 2479908, 2479909, 2479910, 2479911, 2479912, 2479913, 2479914, 2479915, 2479916, 2479917, 2479918, 2479919, 2479920, 2479921, 2479922, 2479923, 2479924, 2479925, 2479926, 2479927, 2479928, 2479929, 2479930, 2479931, 2479932, 2479933, 2479934, 2479935, 2479936, 2479937, 2479938, 2479939, 2479940, 2479941, 2479942, 2479943, 2506614, 2506615, 2506616, 2506617, 2506618, 2506619, 2506620, 2506621, 2506622, 2506623, 2506624, 2506625, 2506626, 2506627, 2506628, 2506629, 2506630, 2506631, 2506632, 2506633, 2506634, 2506635, 2506636, 2506637, 2506638, 2506639, 2506640, 2506641, 2506642, 2506643, 2506644, 2506645, 2506646, 2506647, 2506648, 2506649, 2506650, 2506651, 2506652, 2506653, 2506654, 2506655, 2506656, 2574470, 2574471, 2574472, 2574473, 2574474, 2574475, 2574476, 2574477, 2574478, 2574479, 2574480, 2574481, 2574482, 2574483, 2574484, 2574485, 2655103, 2655104, 2655105, 2655107, 2655108, 2655109, 2655110, 2667683, 2667685, 2667686, 2680108, 2680109, 2680110, 2680111, 2691767, 2691768, 2691769, 2691770, 2691771, 2691772, 2691773, 2691774, 2691775, 2691777, 2691778, 2691779, 2691780, 2691781, 2707017, 2707018, 2707019, 2707020, 2707021.2707022, 2707023, 2707024, 2707025, 2707026, 2707027, 2707028, 2707029, 2707030, 2707031, 2707032, 2707034, 2707035, 2707036, 2707037, 2707038, 2707039, 2707040, 2707041, 2707042, 2707043, 2707044, 2745483, 2745484, 2745485, 2745486, 2745487, 2745488, 2745489, 2745490, 2745491, 2745492, 2745493, 2745494, 2745495, 2745496, 2745497, 2745498, 2745499, 2745500, 2745501, 2745502, 2745503, 2770664, 2770665, 2770666, 2770667, 2770668, 2770669, 2770670, 2770671, 2770672, 2770673, 2770674, 2770675, 2770676, 2770677, 2770678, 2770679, 2770680, 2770681, 2770682, 2770683, 2770684, 2770685, 2770686, 2770687, 2770688, 2770689, 2770690, 2770691, 2770692, 2770693, 2770694, 2770695, 2796050, 2796051, 2796052, 2796053, 2796054, 2796055, 2796056, 2796057, 2796058, 2796059, 2796060, 2796061, 2796062, 2796063, 2796064, 2796065, 2796066, 2796067, 2796068, 2796069, 2796070, 2796071, 2796072, 2796073, 2796074, 2796075, 2796076, 2796077, 2796078, 2796079, 2796080, 2815983, 2815985, 2815986, 2815987, 2815989, 2815990, 2815991, 2815992, 2815995, 2815996, 2815997, 2815998, 2815999, 2818660, 2818661, 2818662, 2818663, 2818664, 2818665, 2818666, 2818667, 2818668, 2818669, 2818670, 2818671, 2818672, 2818673, 2818674, 2818675, 2818676, 2818677, 2871793, 2871794, 2871795, 2871796, 2871797, 2871798, 2871799, 2871800, 2871801, 2871802, 2871803, 2871804, 2871805, 2871806, 2871807, 2871808, 2871809, 2871810, 2871811, 2871812, 2871813, 2871814, 2871815, 2871817, 2871818, 2871819, 2871820, 2871821, 2871822, 2923594, 2923595, 2923596, 2923597, 2923598, 2923599, 2923600, 2923601, 2923602, 2923603, 2923604, 2923605, 2923606, 2923607, 2923608, 2923609, 2923610, 2923611, 2923612, 2923613, 2923614, 2923615, 2923616, 2923617, 2923618, 2923619, 2923620, 2923621, 2923622, 2923623, 2956982, 2956983, 2956984, 2956985, 2956986, 2956987, 2956988, 2956989, 2956990, 2956991, 2956992, 2956993, 2956994, 2956995, 2956996, 2956997, 2956998, 2956999, 2957000, 2957001, 2957002, 2957003, 2957004, 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• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 Nw 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: 888-912-0403
• Manufacturer Reason for Recall: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
• FDA Determined Cause: Process control
• Action: 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 recalls@exac.com. Reach out to Customer Service at cust.svc@exac.com 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.
• Quantity in Commerce: 3793 devices
• Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN
• 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.

• 510(K) Database: 510(K)s with Product Code = LPH and Original Applicant = EXACTECH, INC.