GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH G...
FDA Device Recall #Z-1728-2022 — Class II — August 11, 2022
Recall Summary
| Recall Number | Z-1728-2022 |
| 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 | 11143 DEVICES |
Product Description
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE LINER 28MM SZ H, REF 130-28-28 e. ACUMATCH GXL 0 DEGREE LINER 28MM SZ J, REF 130-28-29 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ G, REF 130-32-27 g. ACUMATCH GXL 0 DEGREE LINER 32MM SZ H, REF 130-32-28 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ J, REF 130-32-29 g. ACUMATCH GXL 0 DEGREE LINER 36MM SZ H, REF 130-36-28 h. ACUMATCH GXL 0 DEGREE LINER 36MM SZ J, REF 130-36-29 i. ACUMATCH GXL 0 DEGREE LINER 36MM SZ K, REF 130-36-30 j. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ E, REF 138-28-25 k. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ F, REF 138-28-26 l. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ G, REF 138-28-27 m. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ H, REF 138-28-28 n. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ J, REF 138-28-29 o. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H, REF 138-36-28 p. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ J, REF 138-36-29 q. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ K, REF 138-36-30 r. ACUMATCH GXL 15 DEG +5 LAT LINER SZG 38MM, REF 138-36-27 s. ACUMATCH GXL 15DEG LINER 28MM SZ D, REF 132-28-24 t. ACUMATCH GXL 15DEG LINER 28MM SZ E, REF 132-28-25 u. ACUMATCH GXL 15DEG LINER 28MM SZ F, REF 132-28-26 v. ACUMATCH GXL 15DEG LINER 28MM SZ G, REF 132-28-27 w. ACUMATCH GXL 15DEG LINER 28MM SZ H, REF 132-28-28 x. ACUMATCH GXL 15DEG LINER 28MM SZ J, REF 132-28-29 y. ACUMATCH GXL 15DEG LINER 28MM SZ K, REF 132-28-30 z. ACUMATCH GXL 15DEG LINER 32MM SZ G, REF 132-32-27 aa. ACUMATCH GXL 15DEG LINER 32MM SZ H, REF 132-32-28 bb. ACUMATCH GXL 15DEG LINER 32MM SZ J, REF 132-32-29 cc. ACUMATCH GXL 15DEG LINER 32MM SZ K, REF 132-32-30 dd.ACUMATCH GXL 15DEG LINER 36MM SZ H, REF 132-36-28 ee. ACUMATCH GXL 15DEG LINER 36MM SZ J, REF 132-36-29 ff. ACUMATCH GXL 15DEG LINER 36MM SZ K, REF 132-36-30 gg. ACUMATCH GXL EXT COV LINER 28MM SZ E, REF 134-28-25 hh. ACUMATCH GXL EXT COV LINER 28MM SZ F, REF 134-28-26 ii. ACUMATCH GXL EXT COV LINER 28MM SZ G, REF 134-28-27 jj. ACUMATCH GXL EXT COV LINER 28MM SZ H, REF 134-28-28 kk. ACUMATCH GXL EXT COV LINER 28MM SZ J, REF 134-28-29 ll. ACUMATCH GXL EXT COV LINER 28MM SZ K, REF 134-28-30 mm. MCS GXL LINER 5/15 DEG 4448X28, REF 104-28-43 nn. MCS GXL LINER 5/15 DEG 5052X28, REF 104-28-44 oo. MCS GXL LINER 5/15 DEG 5458X28, REF 104-28-45 pp. MCS GXL LINER 5/15 DEG 5458X32, REF 104-32-45 qq. MCS GXL LINER 5/15 DEG 6064X32, REF 104-32-46 rr. MCS GXL LINER 5/15 DEG 6064X36, REF 104-36-46 ss. MCS GXL LINER 5/15 DEG 6670X36, REF 104-36-47
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 130-28-25, GUDID 10885862021984, Serial Numbers: 802593, 802599, 803717, 803737, 841318, 841321, 1572107, 1579369, 1580046, 1583363, 1613871, 1613872, 1613873, 1618998, 1638490, 1638492, 1638494, 1990100, 2282432, 2282433, 2282434; b. REF 130-28-26, GUDID 10885862021991, Serial Numbers: 801865, 801867, 801870, 801872, 801882, 801883, 801886, 801902, 803686, 803690, 803691, 803694, 803695, 803701, 848210, 848213, 848217, 848221, 848222, 848223, 848226, 848232, 848233, 848236, 1677105, 1677106, 1677108, 1677109, 1677110, 1677112, 1677113, 1677114, 1677115, 1677116, 1677118, 1677119, 1677121, 1677122, 1677123, 1677124, 1677126, 1677127, 1677128, 1677129, 1677130, 1677131, 2515330, 2787553, 3871934, 3871935, 3871943; c. REF 130-28-27, GUDID 10885862022004, Serial Numbers: 801542, 801544, 801546, 801547, 801554, 801571, 801572, 801578, 801580, 804033, 804034, 804035, 804036, 862139, 862144, 862146, 1681578, 1681579, 1681580, 1681581, 1681583, 1703643, 1727491, 1727492, 1727493, 1727495, 1727496, 1727497, 1727498, 1727499, 1727500, 1727501, 1727502, 1727503, 1727504, 1727505, 1727506, 1727507, 1727508; d. REF 130-28-28, GUDID 10885862022011, Serial Numbers: 801765; e. REF 130-28-29, GUDID 10885862022028, Serial Numbers: 801654; f. REF 130-32-27, GUDID 10885862022097, Serial Numbers: 966203, 966204, 966205, 966207, 966208, 966209, 966210, 966211, 966212, 966213, 966215, 966216, 966217, 966218, 966219, 966220, 966221, 966222, 966223, 966224, 966225, 966226, 966227, 966228, 966229, 966230, 966231, 966232, 966233, 1042377, 1042378, 1042379, 1042381, 1042382, 1042383, 1042384, 1042385, 1042387, 1042388, 1042391, 1042392, 1042394, 1042395, 1042396, 1042397, 1042398, 1042399, 1042400, 1042401, 1042402, 1042405, 1042406, 1042407, 1042408, 1095431, 1095432, 1095433, 1095434, 1095435, 1095436, 1095437, 1095438, 1095439, 1095440, 1095441, 1095443, 1095444, 1095445, 1095446, 1095447, 1095448, 1095449, 1095537, 1095538, 1095539, 1095541, 1095542, 1095545, 1095546, 1095547, 1095548, 1095550, 1308088, 1308090, 1308092, 1308093, 1308094, 1308095, 1308096, 1308098, 1308102, 1308103, 1308104, 1308105, 1308106, 1308109, 1308111, 1308113, 1308115, 1308116, 1308117, 1308118, 1308119, 1308120, 1984610, 1984611, 1984612, 1984613, 1984614, 1984616, 2053081, 2075035, 2075037, 2075038, 2075039, 2075040, 2075041, 2075042, 2075043, 2075044, 2075045, 2075046, 2075048, 2075049, 2075050, 2075051, 2398494, 2398496, 2398499, 2517474, 2517476, 2517478, 3818434, 3818437, 3818439, 3818444, 3818447; g. REF 130-32-28, GUDID 10885862022103, Serial Numbers: 966299, 966302, 966305, 966307, 966308, 966312, 966313, 966316, 966317, 966318, 966321, 966322, 966327, 1090743, 1090745; f. REF 130-32-29, GUDID 10885862022110, Serial Numbers: 969025, 969026, 969031, 969043; g. REF 130-36-28, GUDID 10885862022202, Serial Numbers: 967669, 967670, 967671, 967672, 967673, 967674, 967675, 967676, 967677, 967678, 967680, 967681, 967683, 967684, 967685, 967686, 967687, 967688, 967689, 967690, 967691, 967692, 967693, 967694, 967695, 967698, 967699, 967700, 967701, 1051661, 1051662, 1051663, 1051664, 1051665, 1051666, 1051667, 1051669, 1051670, 1085957, 1085959, 1085960, 1085961, 1085962, 1085963, 1085964, 1085965, 1085966, 1116002, 1116003, 1116005, 1116006, 1116007, 1116008, 1116009, 1116010, 1116011, 1116012, 1160079, 1160080, 1160081, 1160082, 1160083, 1160084, 1160085, 1160086, 1160087, 1160089, 1206218, 1206219, 1206223, 1206224, 1206225, 1206226, 1668596, 1668597, 1668598, 1668599, 1668600, 1668601, 1668602, 1668603, 1668604, 1668605, 2112376, 2112377, 2112381, 2112382, 2112383, 2112384, 2140027, 2140028, 2504302, 2537040, 2710341, 3871865, 4984351; h. REF 130-36-29, GUDID 10885862022219, Serial Numbers: 975034, 975035, 975036, 975037, 975038, 975040, 975041, 975042, 975043, 975044, 975046, 975047, 975048, 975049, 975050, 975053, 975054, 975055, 975057, 975059, 975063, 1111355, 1111357, 1111358, 1111359, 1111361, 1121576, 1121578, 1121584, 1300472, 1300476, 1300477, 1984741, 1984743, 1984744, 3877076, 3877077, 3877094; i. REF 130-36-30, GUDID 10885862022226, Serial Numbers: 1880259, 1880260, 1880261, 1880262, 1880263, 1880264, 1880265, 1880266, 1880267, 1880268; j. REF 138-28-25, GUDID 10885862024589, Serial Numbers: 805443, 805445, 830281, 830311, 1093756, 1093757, 1632712, 1632713, 1632714, 1632715, 1632716, 1632717, 1662735, 1662736, 1662737, 1667712, 1667715, 1667716, 1667717, 1667718, 1667723, 1667725, 1667726, 1667727, 1667728, 3873889; k. REF 138-28-26, GUDID 10885862024596, Serial Numbers: 805410, 805413, 805421, 805431, 830169, 830177, 830179, 830183, 830184, 830203, 830207, 830209, 830214, 1063813, 1063818, 1063821, 1063830, 1063831, 1737026, 1737027, 1737028, 1737029, 1737030, 1737031, 1737032, 1737033, 2042361, 2042363, 2042364, 2042366, 2042369, 2042372, 2042373, 3840141; l. REF 138-28-27, GUDID 10885862024602, Serial Numbers: 805797, 805799, 805802, 805805, 805806, 805807, 805809, 805810, 805811, 805812, 805816, 805818, 805819, 805820, 805821, 825944, 825949, 825951, 825956, 825961, 825967, 825969, 825970, 825973, 825977, 825978, 825982, 825987, 1063928, 1063941, 2077678, 2077685, 2089964, 3641016, 3873936, 3949986, 3949987; m. REF 138-28-28, GUDID 10885862024619, Serial Numbers: 805355, 805363, 805370, 826263, 826270, 826272, 826275, 1063978; n. REF 138-28-29, GUDID 10885862024626, Serial Numbers: 805827, 805831, 826312, 1063872, 1063889; o. REF 138-36-28, GUDID 10885862024824, Serial Numbers: 807111, 807112, 807113, 807114, 807116, 807119, 807120, 807121, 807122, 807123, 807124, 807125, 807126, 807127, 807128, 807129, 832731, 832732, 832733, 832734, 832735, 832736, 832737, 832738, 832739, 832740, 832742, 832745, 832747, 832748, 832750, 832752, 832754, 832756, 832757, 832758, 832759, 832761, 832763, 832764, 832765, 832767, 832768, 832769, 832770, 832771, 832772, 832773, 832774, 832775, 1019498, 1019499, 1019500, 1019501, 1062910, 1062911, 1062912, 1062913, 1062915, 1062917, 1062918, 1062919, 1062925, 1062927, 1062928, 1223016, 1223017, 1223018, 1223019, 1223022, 1223024, 1223025, 1223026, 1223030, 1223032, 1223033, 1223035, 1223038, 1223039, 1223041, 1900707, 1900708, 1900709, 1900710, 1900711, 1900712, 1920463, 1920464, 1920466, 1920467, 1920468, 1920469, 1920470, 1920471, 1973173, 1973174, 1973175, 1973176, 1973177, 2042392, 2042394, 2313822, 2515477, 2515478, 2800310, 2914514, 2914515, 2914516, 2914517, 2914519, 2914520, 4127080, 4127085, 4127087, 4127089; p. REF 138-36-29, GUDID 10885862024831, Serial Numbers: 807004, 807006, 807013, 807014, 807015, 807017, 807018, 807022, 832683, 832684, 832685, 832686, 832687, 832688, 832690, 832692, 832693, 832694, 832695, 832697, 832698, 832699, 832700, 832706, 832715, 832716, 832717, 832718, 832722, 832723, 832724, 832730, 1086653, 1086658, 1086660, 1086662, 1086665, 1086666, 1086668, 1086672, 1086673, 1636898, 1636900, 1636905, 1636906, 1636908, 1636912, 2102752, 2102757, 2102768, 4127096; q. REF 138-36-30, GUDID 10885862024848, Serial Numbers: 1601226, 1619050, 1619053, 1619054, 1619055. 1619056, 1781527; r. REF 138-36-27, GUDID 10885862024817, Serial Numbers: 1803304; s. REF 132-28-24, GUDID 10885862023063, Serial Numbers: 774713, 775770, 780332, 780345, 780350, 780361, 832888, 832889, 832892, 832893, 832895, 832896, 832897, 832898, 832899, 832907, 832910, 832911, 832913, 832916, 832917, 832918, 832919, 832920, 832921, 832927, 832928, 1425136, 1425137, 1425138, 1425139, 1425140, 1425141, 1425142, 1425143, 1425144, 1461022, 1461023, 1461024, 1461025, 1461026, 1461027, 1461028, 1461029, 1461030, 1461031, 1468006, 1468007, 1468008, 1468011, 1468013, 1500600, 1500601, 1500604, 1500605, 1500606, 1500607, 1506186, 1506187, 1506189, 1506191, 1506193, 1506709, 1506711, 1506712, 1506713, 1506715, 1539850, 1539851, 1547645, 1547646, 1547647, 1547650, 1553669, 1553670, 1553671, 1553673, 1583122, 1583123, 1583124, 1606151, 1606152, 1606155, 1606156, 1606162, 1606163, 1606164, 1606165, 1606166, 1606167, 1606169, 1606170, 1606173, 1606174, 1606175, 1726208, 1726209, 1726211, 1726212, 1726213, 1726214, 1726216, 1726217, 1726218, 1726219, 1726220, 1726221, 1726222, 1726224, 1726225, 1726226, 1726227, 1726228, 1726229, 1726230, 1726232, 1726233, 1726234, 1797506, 1797509, 1797510, 1797511, 1797513, 1797515, 1797516, 1797519, 1797520, 1797521, 1797522, 1797523, 1797524, 1797525, 1797527, 1797528, 1857368, 1857369, 1857370, 1945042, 1945043, 1945044, 1945046, 1945047, 1945048, 1945049, 1945052, 1945054, 1945055, 1945056, 1945057, 1945058, 1945059, 1945061, 1945062, 2420338, 2420339, 2420340, 2420341, 2420342, 2420343, 2574499, 2574500, 2574501, 2574502, 2574503, 2574504, 2574505, 2673229, 2673231, 2673233, 2673235, 2673236, 2673237, 2673238, 2673239, 2673240, 2767967, 2767981, 3863516; t. REF 132-28-25, GUDID 10885862023070, Serial Numbers: 772272, 772273, 772274, 772275, 772277, 772278, 772280, 772281, 772283, 772284, 772285, 774527, 774530, 774531, 774534, 774535, 774536, 780857, 780858, 780859, 780860, 780861, 780862, 780863, 780867, 780870, 781762, 781763, 781765, 781767, 781768, 781769, 795983, 795984, 795987, 795988, 795989, 795990, 795991, 795994, 795996, 795998, 795999, 796001, 796002, 796003, 796005, 796006, 796007, 796008, 796009, 796011, 796012, 796013, 796014, 796015, 796016, 796017, 796019, 796020, 848240, 848242, 848243, 848244, 848245, 848246, 848248, 848252, 848254, 848256, 848258, 848260, 848526, 848527, 848529, 848530, 848534, 848536, 848537, 848538, 848539, 848541, 848542, 848543, 848545, 848546, 848547, 848549, 848550, 848551, 848554, 848555, 848556, 848558, 848560, 848562, 848563, 848565, 848566, 848567, 848568, 848569, 848570, 848571, 848572, 848573, 848575, 848576, 848577, 1061548, 1061549, 1061550, 1061551, 1061552, 1061553, 1061554, 1061555, 1061556, 1061557, 1061558, 1061559, 1061561, 1061562, 1061567, 1061568, 1061569, 1061570, 1061571, 1061572, 1061573, 1061574, 1061575, 1061576, 1061577, 1061578, 1061579, 1061580, 1160004, 1160005, 1160006, 1160007, 1160008, 1160009, 1160010, 1160011, 1160012, 1160013, 1160014, 1160015, 1160016, 1160017, 1160018, 1160019, 1160020, 1160021, 1160022, 1160023, 1160024, 1160025, 1160026, 1160027, 1160028, 1160029, 1160030, 1160031, 1160032, 1160033, 1160034, 1160035, 1160036, 1202519, 1202520, 1202521, 1202522, 1202523, 1202524, 1202525, 1202526, 1202527, 1202528, 1202529, 1202530, 1202531, 1202532, 1202533, 1202534, 1202535, 1202536, 1202537, 1202538, 1202539, 1202540, 1202541, 1202542, 1202543, 1202544, 1202545, 1202546, 1202547, 1202548, 1202549, 1202550, 1202551, 1202552, 1202553, 1202554, 1202555, 1202556, 1377964, 1377965, 1377966, 1377967, 1377968, 1377969, 1377970, 1377971, 1377972, 1377973, 1380135, 1380136, 1380137, 1380138, 1380139, 1431888, 1431889, 1431890, 1431891, 1431892, 1431893, 1431894, 1431895, 1431896, 1431897, 1433056, 1433057, 1433058, 1433059, 1433060, 1433061, 1433062, 1458382, 1458383, 1458384, 1458385, 1458386, 1458387, 1458388, 1458389, 1458390, 1458391, 1458392, 1458393, 1458394, 1458395, 1458396, 1458847, 1458848, 1458849, 1458850, 1458851, 1458852, 1458853, 1489124, 1489125, 1489126, 1489128, 1489129, 1489130, 1489131, 1489132, 1489133, 1489134, 1489135, 1489136, 1489137, 1489138, 1489140, 1489141, 1489142, 1489143, 1489144, 1489145, 1489146, 1489147, 1489148, 1489149, 1489150, 1502678, 1502679, 1502683, 1502684, 1502685, 1502686, 1502687, 1502688, 1502689, 1502690, 1502693, 1502694, 1502695, 1502696, 1502698, 1502699, 1502700, 1502701, 1527446, 1527447, 1527448, 1527449, 1527450, 1527452, 1527453, 1527454, 1527455, 1527456, 1527457, 1527458, 1527459, 1527460, 1527461, 1527462, 1527463, 1527464, 1527465, 1527466, 1527468, 1527469, 1527470, 1586106, 1586108, 1586109, 1586110, 1586111, 1586112, 1586113, 1586114, 1586115, 1586116, 1586117, 1586118, 1586119, 1586120, 1586121, 1586122, 1586123, 1586125, 1586127, 1586128, 1586129, 1586130, 1586131, 1586133, 1586134, 1586135, 1586136, 1586137, 1586138, 1586139, 1586140, 1586141, 1586142, 1586143, 1586144, 1586145, 1586146, 1587461, 1587462, 1587463, 1587464, 1587465, 1587466, 1587467, 1587468, 1587471, 1587472, 1587474, 1587475, 1587476, 1587477, 1587478, 1587479, 1587480, 1587481, 1587482, 1587483, 1587486, 1587488, 1587489, 1587490, 1587491, 1587492, 1587493, 1587494, 1587496, 1587497, 1713627, 1713628, 1713629, 1713630, 1713631, 1713632, 1713633, 1713634, 1713635, 1713636, 1713637, 1713638, 1713639, 1713640, 1713641, 1713642, 1713643, 1713644, 1713645, 1713646, 1713647, 1713648, 1713649, 1713650, 1713651, 1713652, 1779520, 1779521, 1779522, 1779524, 1779525, 1779527, 1779528, 1779529, 1779530, 1779531, 1779532, 1779533, 1779534, 1779536, 1779537, 1779539, 1779540, 1779541, 1779542, 1779543, 1779545, 1779546, 1781473, 1781474, 1781476, 1781477, 1781478, 1781479, 1781480, 1781481, 1781482, 1781483, 1781484, 1781485, 1781486, 1781487, 1781488, 1781489, 1781490, 1781491, 1781492, 1781493, 1781494, 1781495, 1781496, 1781497, 1781498, 1781499, 1781500, 1781501, 1781503, 1781504, 1781505, 1781506, 1781507, 1781508, 1781509, 1781510, 1781512, 1781514, 1781515, 1781516, 1781517, 1781518, 1781519, 1781520, 1781521, 1781522, 1781523, 1781524, 1873693, 1873694, 1873696, 1873697, 1873698, 1873699, 1873700, 1873701, 1873702, 1873703, 1873704, 1873705, 1873706, 1873707, 1873708, 1873709, 1873710, 1873711, 1873712, 1873713, 1873714, 1873715, 1873716, 1873717, 1873718, 1873719, 1873720, 1873721, 1873722, 1873723, 1873724, 2244826, 2244827, 2244828, 2244829, 2244830, 2244831, 2244832, 2244833, 2244834, 2244835, 2244836, 2244837, 2244838, 2244839, 2244840, 2244841, 2244842, 2244843, 2244844, 2244845, 2244846, 2244847, 2244848, 2244849, 2244850, 2244851, 2244852, 2396247, 2396248, 2396249, 2396250, 2396251, 2396252, 2396253, 2396254, 2396255, 2396256, 2396257, 2396258, 2396259, 2396260, 2396261, 2396262, 2396263, 2396264, 2396265, 2396266, 2396267, 2396268, 2396269, 2396270, 2396271, 2396272, 2396273, 2575428, 2575429, 2575430, 2575431, 2575432, 2575433, 2575434, 2575435, 2575436, 2575437, 2575438, 2575439, 2575440, 2575441, 2575442, 2575443, 2575444, 2575445, 2575446, 2575447, 2575449, 2575450, 2575451, 2575452, 2575453, 2575454, 2687702, 2687703, 2687704, 2687705, 2687706, 2687707, 2687709, 2687710, 2687711, 2687712, 2687713, 2687716, 2687717, 2687720, 2687722, 2687723, 2687724, 2687725, 2687726, 2847932, 2847934, 2847935, 2847936, 2847937, 2847938, 2847939, 2847941, 2847942, 2847943, 2993028, 2993030, 2993031, 2993033, 2993034, 2993035, 2993036, 2993037, 2993040, 2993041, 2993042, 3558245, 3558247, 3558249, 3558262, 3558265, 3665411, 3689528, 3689529, 3689535, 3689536, 3852374, 3852376, 4127030, 4127032, 4127037, 4127044, 5246611, 5246612, 5246613, 5246614, 5246615, 6230836, 6230837; u. REF 132-28-26, GUDID 10885862023087, Serial Numbers: 768376, 768377, 768378, 768379, 768380, 768381, 768382, 768383, 768384, 768385, 768386, 768387, 775736, 775739, 775740, 775741, 775742, 775743, 775744, 775745, 775747, 775748, 775749, 775750, 775751, 775752, 775753, 775755, 775756, 775757, 775759, 775760, 775761, 775762, 775763, 779211, 779212, 779213, 779214, 779215, 779217, 779219, 779220, 779221, 779222, 779223, 779224, 779225, 779226, 779227, 779229, 779230, 779231, 779232, 779233, 779234, 779235, 779236, 779237, 779238, 779239, 779241, 779242, 779244, 779245, 779246, 779247, 779250, 779251, 779252, 779253, 779254, 779255, 779256, 779257, 779258, 779259, 779260, 779261, 779262, 779263, 779264, 779266, 779267, 779268, 779269, 779271, 779272, 779273, 779274, 779275, 779276, 779277, 779278, 779279, 779280, 779281, 779282, 779283, 779284, 779285, 779286, 779287, 779290, 779291, 779293, 779294, 779295, 779296, 779297, 779298, 779299, 779300, 779301, 779302, 779303, 779304, 779305, 779306, 779307, 779308, 779309, 779310, 779311, 779312, 779313, 779314, 779315, 779316, 779317, 779318, 779319, 779320, 779321, 779322, 780895, 780896, 780897, 841129, 841130, 841131, 841132, 841133, 841134, 841135, 841136, 841137, 841138, 841141, 841142, 841143, 841144, 841145, 841146, 841147, 841148, 841149, 841150, 841151, 841152, 841153, 841154, 841155, 841156, 841157, 841158, 841159, 841160, 841161, 841162, 841163, 841164, 841167, 841168, 841169, 841170, 841171, 841172, 841173, 841174, 841175, 841176, 841177, 841178, 841939, 841940, 841941, 841942, 841943, 841944, 841945, 841946, 841947, 841948, 841950, 841951, 841952, 841953, 841954, 841955, 841956, 841957, 841958, 841959, 841960, 841961, 841962, 841963, 841964, 841966, 841967, 841968, 841969, 841970, 841971, 841972, 841973, 841974, 841976, 841978, 841979, 841980, 841982, 841984, 841985, 841986, 841987, 841988, 841989, 841990, 841991, 850008, 850009, 850010, 850013, 850014, 850017, 850019, 850020, 850021, 850022, 850023, 850024, 850025, 850026, 850027, 850028, 850029, 850030, 850031, 850032, 850033, 850034, 850035, 850036, 850037, 850038, 850039, 850040, 850041, 850042, 850044, 850045, 850046, 850047, 850048, 850049, 850050, 850051, 850052, 850054, 1051615, 1051616, 1051617, 1051618, 1051619, 1051620, 1051621, 1051622, 1051623, 1051624, 1051625, 1051626, 1051627, 1051628, 1051630, 1051631, 1051632, 1051633, 1051634, 1051635, 1051636, 1051638, 1051640, 1051641, 1051642, 1051643, 1051644, 1051645, 1051646, 1087087, 1087088, 1087089, 1087090, 1087091, 1087094, 1087095, 1087096, 1087097, 1087099, 1087100, 1087101, 1087102, 1087103, 1087104, 1087105, 1087106, 1087108, 1087110, 1087111, 1087112, 1087113, 1087114, 1087115, 1087116, 1087117, 1087118, 1087119, 1145083, 1145084, 1145085, 1145086, 1145087, 1145088, 1145089, 1145090, 1145091, 1145092, 1145093, 1145094, 1145095, 1145096, 1145097, 1145098, 1145099, 1145100, 1145101, 1145102, 1145103, 1145104, 1145105, 1145106, 1145107, 1145108, 1145109, 1202558, 1202559, 1202560, 1202561, 1202562, 1202563, 1202564, 1202565, 1202566, 1202567, 1202568, 1202569, 1202570, 1202571, 1202572, 1202573, 1202574, 1202575, 1202576, 1202577, 1202578, 1202579, 1202580, 1202581, 1202582, 1202583, 1202584, 1202585, 1202586, 1202587, 1202588, 1202589, 1342362, 1342363, 1342364, 1342365, 1342366, 1342367, 1342368, 1342369, 1342370, 1342371, 1342372, 1342373, 1342374, 1342375, 1342376, 1342377, 1342378, 1342379, 1342380, 1342381, 1358274, 1358275, 1358276, 1358277, 1358279, 1358280, 1358281, 1358282, 1358283, 1358284, 1358285, 1358286, 1377442, 1377443, 1377444, 1377445, 1377446, 1377447, 1377448, 1377449, 1377450, 1377451, 1377452, 1377453, 1377454, 1377455, 1377456, 1377457, 1377458, 1377459, 1377460, 1377461, 1377462, 1377463, 1377464, 1377465, 1377466, 1377467, 1377468, 1377469, 1377470, 1377471, 1377472, 1377473, 1377474, 1404991, 1404992, 1404993, 1404994, 1404995, 1404996, 1404997, 1404998, 1404999, 1405000, 1405001, 1405002, 1405003, 1405004, 1405005, 1405006, 1405007, 1405008, 1405009, 1405010, 1405011, 1405012, 1405013, 1405014, 1405015, 1405016, 1405017, 1405018, 1405019, 1405020, 1405021, 1405022, 1405023, 1405024, 1405025, 1405026, 1405027, 1405028, 1405029, 1405030, 1405031, 1405032, 1405033, 1405034, 1405035, 1405036, 1405037, 1405038, 1405039, 1405040, 1405041, 1405042, 1405043, 1405044, 1405045, 1405046, 1405047, 1405048, 1405049, 1405050, 1405051, 1405052, 1405053, 1405054, 1407084, 1407085, 1407086, 1407087, 1407088, 1407089, 1407090, 1407091, 1407092, 1407093, 1407094, 1407095, 1407096, 1407097, 1407098, 1407099, 1407100, 1407101, 1407102, 1407103, 1407104, 1407105, 1407106, 1407107, 1407108, 1407109, 1407110, 1407111, 1407112, 1407113, 1407114, 1407115, 1407116, 1407117, 1407118, 1407119, 1407120, 1407121, 1407122, 1407123, 1407124, 1407125, 1407126, 1407127, 1407128, 1407129, 1407130, 1407131, 1407132, 1407133, 1407134, 1407135, 1407136, 1407137, 1407138, 1407139, 1407140, 1407141, 1407142, 1407143, 1407144, 1407145, 1407146, 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1511500, 1511501, 1511502, 1511503, 1511504, 1511505, 1511506, 1511507, 1511508, 1511509, 1543436, 1543437, 1543438, 1543439, 1543440, 1543441, 1543442, 1543443, 1543444, 1543445, 1543446, 1543447, 1543448, 1543449, 1543450, 1543451, 1543452, 1543453, 1543454, 1543455, 1543456, 1543457, 1543458, 1543459, 1543460, 1543461, 1543462, 1543463, 1543464, 1543465, 1543466, 1543467, 1543468, 1543469, 1543470, 1543471, 1543472, 1543473, 1543474, 1543475, 1543476, 1543477, 1543478, 1543479, 1543480, 1543481, 1543482, 1543483, 1543484, 1543485, 1571042, 1571043, 1571044, 1571045, 1571046, 1571047, 1571048, 1571049, 1571050, 1571051, 1571052, 1571053, 1571054, 1571055, 1571056, 1571057, 1571058, 1571059, 1571060, 1571061, 1571062, 1571063, 1571064, 1571065, 1571066, 1571067, 1571068, 1571069, 1571070, 1571071, 1571072, 1571073, 1571074, 1583131, 1583132, 1583133, 1583134, 1583135, 1583136, 1583137, 1583138, 1583139, 1583140, 1583141, 1583142, 1583143, 1583144, 1583145, 1583146, 1583147, 1583148, 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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.