Z-0020-2022Class II
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines...
Exactech, Inc. / initiated 2021-08-30 / Open, Classified / root cause: manufacturing process
Exactech, Inc. began a recall of OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE... on . FDA classified it as Class II and gives the reason as "Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0020-2022
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Exactech, Inc.
- Product
- OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
- Product code
- HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- Reason for recall
- Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- Root cause tag
- manufacturing process
- FDA root cause
- 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 [email protected]. 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
- 2,774 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 .
- Product codes and lots
- Item Number (Device Identifier; Serial number(s)): 252-12-01 (10885862065759; 0757895, 0757903, 0757904, 0757912, 0779752, 0779753, 0779755, 0779756, 0779757, 0779761, 0779762, 0779763, 0779764, 0779765, 0779766, 0779768, 0779769, 0779771, 1411813, 1411814, 1411816, 1454118, 1454120, 1454121, 1454122, 1637857, 1637859, 1637862, 1637863, 1705486, 1705487, 1705488, 1705489, 1705491, 1705492, 1705499, 1705500, 1777268, 1777272, 1838362, 1838363, 1838366, 1845014, 1845017, 1845018, 1876225, 1876228, 1876229, 1966561, 1966562, 1966563, 1966565, 2058877, 2058880, 2058883, 2236096, 2236097, 2236100, 2388362, 2388363, 2388364, 2388365, 2782155, 2787073, 2787075, 2787076, 3664728, 3664729, 4149824, 4149840); 252-12-02 (10885862065766; 1064337, 1064339, 1064340, 1064341, 1064342, 1064343, 1064344, 1064345, 1064347, 1064348, 1064349, 1064350, 1064351, 1064352, 1064353, 1064354, 1064355, 1064356, 1064357, 1064358, 1257124, 1257125, 1257126, 1257127, 1257128, 1257130, 1257131, 1257132, 1257135, 1257136, 1257138, 1257141, 1257145, 1257146, 1257147, 1257148, 1257149, 1257150, 1257151, 1257152, 1257153, 1257154, 1257156, 1257157, 1257158, 1257159, 1257160, 1257163, 1257164, 1257165, 1257166, 1257167, 1257168, 1257169, 1257170, 1257171, 1257173, 1257175, 1257176, 1257177, 1257178, 1257179, 1257181, 1856545, 1856546, 1856547, 1856549, 1856550, 1856551, 1856552, 1856554, 1896395, 1896396, 1896397, 1896398, 1896399, 1896400, 1896401, 1896404, 2116639, 2116640, 2116641, 2116642, 2116644, 2288472, 2328963, 2328964, 2328965, 2328966, 2328968, 2509909, 2509911, 2566818, 2649854, 2692694, 2728962, 2728968, 2728971, 2728976, 2728977, 2728979, 2728980, 2728981, 2728988, 2728991, 3808095, 3808101, 3808110, 3808112, 3808116); 252-12-03 (10885862065773; 0764379, 0764380, 0764381, 0764382, 0764384, 0764385, 0764386, 0764387, 0764389, 0764390, 0764391, 0764392, 0764393, 0764394, 0764395, 0764396, 0764398, 0764400, 0764401, 0764402, 0764407, 0766178, 0766179, 0766180, 0766181, 0766182, 0766183, 0766185, 0766188, 0766189, 0766191, 0766193, 0766194, 0766195, 0766196, 0766198, 0766199, 0766200, 1152751, 1152756, 1152758, 1152759, 1152760, 1152763, 1152764, 1152765, 1152767, 1152768, 1152769, 1248425, 1248426, 1248427, 1248429, 1248430, 1248431, 1248432, 1248433, 1248434, 1248435, 1248437, 1248438, 1248439, 1248440, 1248441, 1248442, 1248443, 1248444, 1248445, 1248446, 1248447, 1248448, 1248449, 1248450, 1294270, 1294271, 1294272, 1294273, 1294274, 1294275, 1294276, 1294277, 1294278, 1294279, 1434902, 1434903, 1434904, 1434905, 1434906, 1434907, 1434908, 1434909, 1434910, 1510648, 1510649, 1510650, 1510651, 1526390, 1526391, 1526392, 1526393, 1545560, 1545561, 1548840, 1548841, 1548842, 1617606, 1617607, 1617608, 1617609, 1617610, 1617611, 1618554, 1618555, 1618556, 1618557, 1618558, 1706098, 1706099, 1706100, 1706101, 1706102, 1706104, 1706105, 1706106, 1706107, 1706108, 1706109, 1706110, 1778471, 1778472, 1778473, 1778474, 1778475, 1778476, 1778477, 1778478, 1778479, 1778480, 1778481, 1778482, 1778483, 1778484, 1778485, 1778486, 1778487, 1825147, 1825148, 1825149, 1825150, 1825151, 1825153, 1846127, 1846128, 1846129, 1846130, 1846131, 1846132, 1846133, 1846134, 1846135, 1846136, 1846137, 1933648, 1933649, 1933650, 1933651, 1936093, 1936094, 1936095, 2002988, 2002989, 2002990, 2002991, 2002992, 2002993, 2002994, 2049677, 2049678, 2049679, 2049680, 2049681, 2060180, 2087493, 2087494, 2087495, 2087496, 2087497, 2087498, 2087499, 2087500, 2087502, 2087503, 2087504, 2087506, 2087507, 2205053, 2205054, 2205055, 2205057, 2233544, 2233545, 2233548, 2233549, 2233550, 2233551, 2233553, 2233554, 2233555, 2233556, 2233557, 2233558, 2512172, 2512173, 2567163, 2567164, 2567165, 2567166, 2567168, 2567169, 2567171, 2567172, 2787069, 2787070, 2787071, 2787072, 2829262, 2829263, 2829264, 2906611, 2906612, 2906613, 2991360, 2991362, 2991363, 2991365, 3564018, 3564020, 3564021, 3564022, 3564023, 3564024, 3564025, 3564026, 3691658, 3808084, 3808085, 3808086, 3808089, 3808093, 4279265, 4279268, 4279270, 4279271, 4488796, 4677196, 5839504, 5839509, 5839510, 5839512, 5839513, 5839514, 5839517, 5839518, 5839519, 5839528, 5839531, 5839532, 5839533, 5839534, 5839535, 5839536, 5839537, 5839538, 5839539, 5839540, 5839541, 5839542, 5839543, 5839545, 5839549, 5839550, 5839557, 5839560); 252-12-04 (10885862065780; 1085902, 1085903, 1085904, 1085905, 1085906, 1085907, 1085908, 1085909, 1085911, 1085914, 1085915, 1085916, 1085917, 1085918, 1085919, 1085920, 1085921, 1085922, 1085923, 1085924, 1174118, 1174119, 1174120, 1174121, 1174122, 1174123, 1174124, 1174125, 1174126, 1174127, 1174129, 1174130, 1174131, 1174132, 1174133, 1174134, 1174136, 1174137, 1174139, 1174140, 1174141, 1174142, 1174143, 1174144, 1174145, 1174146, 1174147, 1174148, 1174149, 1174150, 1174151, 1174152, 1174153, 1174154, 1174155, 1174156, 1174157, 1174158, 1174159, 1174160, 1174161, 1174162, 1174163, 1174164, 1174165, 1174166, 1174168, 1174169, 1174170, 1174171, 1544907, 1544908, 1544909, 1544910, 1600619, 1600620, 1600621, 1600622, 1600623, 1600624, 1600625, 1600626, 1600627, 1600628, 1600629, 1603583, 1603584, 1603585, 1603586, 1603587, 1603588, 1603589, 1603590, 1603591, 1603592, 1603593, 1603594, 1603595, 1603596, 1603597, 1838244, 1838245, 1838247, 1838248, 1838250, 1838251, 1838252, 1838253, 1838254, 1838255, 1838256, 1838257, 1838258, 1838259, 1838260, 1838261, 1876049, 1876050, 1876051, 1876052, 1876053, 1876054, 1876055, 1876056, 1876057, 1876058, 1877196, 1877197, 1877198, 1877199, 1877200, 1877201, 1877203, 1877204, 1877205, 1877206, 1877207, 1877209, 1877210, 2080039, 2080040, 2080041, 2080042, 2080043, 2080044, 2080048, 2080049, 2080050, 2080051, 2204986, 2204987, 2235110, 2235111, 2235112, 2235113, 2235114, 2235115, 2235116, 2235117, 2235118, 2235119, 2235121, 2235122, 2235124, 2567173, 2567174, 2742317, 2742318, 2742319, 2742320, 2742321, 2742322, 2742323, 2892691, 2892692, 2892693, 2892694, 2892695, 2980254, 2980255, 2980256, 2980257, 2980258, 2980259, 2980260, 2980262, 2980263, 2980264, 2980265, 2980266, 2980267, 2995492, 2995494, 2995496, 2995498, 2995500, 2995502, 3624142, 3624143, 3624145, 3624148, 3624150, 3728981, 3755632, 3791754, 3791756, 3791757, 3791758, 3791759, 3971565, 3971566, 3971567, 3971568, 3971569, 3971570, 4019996, 4019997, 4019998, 4020000, 4058269, 4058270, 4058271, 4298553, 4298556, 4298557, 4298558, 4298560, 4298561, 4298563, 4298564, 4298565, 4298566, 4719674, 4719677); 252-12-05 (10885862065797; 0764354, 0764356, 0764358, 0764359, 0764360, 0764361, 0764363, 0764364, 0764366, 0764367, 0764368, 0764369, 0764371, 0764372, 0776484, 0776485, 0776486, 0776487, 0776489, 0776491, 0776492, 0776497, 0776499, 0776500, 0776501, 0776502, 0776505, 0776506, 0776507, 0776508, 1344152, 1344153, 1344155, 1344156, 1344157, 1344158, 1344159, 1344160, 1344161, 1413174, 1413175, 1413176, 1413177, 1429614, 1429615, 1429616, 1429617, 1429618, 1429619, 1429620, 1429621, 1429622, 1429623, 1443143, 1443144, 1443145, 1443146, 1443147, 1513762, 1513763, 1513764, 1513765, 1513766, 1513767, 1513768, 1513769, 1513770, 1513771, 1722792, 1722794, 1722796, 1722797, 1722799, 1722800, 1722802, 1722803, 1722804, 1722805, 1722806, 1786482, 1786483, 1786485, 1786486, 1786487, 1786488, 1786492, 1786494, 1786495, 1786496, 1845431, 1845433, 1845435, 1932090, 1932091, 1932092, 1932093, 1932094, 2039276, 2049683, 2138747, 2138748, 2138749, 2138750, 2138751, 2138752, 2152317, 2152318, 2152319, 2152320, 2152322, 2236090, 2236091, 2236094, 2236095, 2287646, 2287648, 2287649, 2287650, 2351082, 2351083, 2351084, 2464982, 2464983, 2567177, 2782410, 2782411, 2796910, 2796911, 2796912, 2796913, 2796915, 2796916, 2877828, 2877831, 2965401, 2965402, 2965403, 2991358, 3122647, 3122648, 3122649, 3122650, 3546828, 3546829, 3546831, 3669732, 3669733, 3669735, 3669736, 3669737, 3699151, 3699152, 3808117, 3808118, 3808119, 3808120, 3808122, 4005870, 4005871, 4005872, 4005873, 4005874, 4046964, 4046965, 4133012, 4133014, 4133015, 4133017, 4133020, 4133021, 4133024, 4133028, 4133030, 4133032, 4133033, 4133034, 4133035); 252-12-06 (10885862065803; 0764251, 0764255, 0764256, 0764258, 0764260, 0764261, 0764264, 0764265, 0764267, 0764268, 1527895, 1704849, 1704850, 1704851, 1704853, 1704855, 1705430, 1705431, 1774436, 1774437, 1774438, 1774439, 1790515, 1790521, 1790522, 1790523, 1790524, 1790525, 1790526, 2502380, 2535994, 2535995, 2535996, 2535997, 2535998, 2535999, 2536000, 2566819, 2566820, 2566821, 2742308, 2742309, 2742310, 2742311, 2742312, 2742314, 2742315, 2742316, 2906750, 2972415, 2972418, 2972419, 3669846, 3728978, 3792365, 3808124, 3808125, 3808126, 3808127, 3808131, 3965029, 3965030, 3965031, 3965032, 3965033, 3965034, 3965035, 3965036, 4093360, 4093361, 4093362, 4093363, 4093364, 4093365, 4093366, 4093367, 4093368, 4093369, 4093370, 4093372, 4093373, 4093374, 4149809, 4149813, 4149820, 4149821, 4149822); 252-13-01 (10885862065810; 0757154, 0757157, 0757162, 0757164, 0757167, 0757168, 0757169, 0757172, 0757173, 0779683, 0779687, 0779688, 0779690, 0779695, 0779698, 0779700, 0779702, 0779704, 0779705, 0779706, 1444543, 1444544, 1444546, 1444547, 1454184, 1637927, 1637931, 1637932, 1637934, 1637941, 1772248, 1772249, 1772250, 1772251, 1772252, 1772253, 1772254, 1772259, 1772260, 1772262, 1772265, 1772267, 1772268, 1772269, 1772270, 1772271, 1772273, 1997498, 2025207, 2025209, 2025210, 2025211, 2059074, 2059076, 2059077, 2059082, 2059083, 2350825, 2350826, 2350828, 2350829, 2446052, 2446054, 2446057, 2446058, 3669847, 3669848, 3728983, 3728984, 3808079, 3808080, 4361052); 252-13-02 (10885862065827; 1019275, 1019276, 1019277, 1019278, 1019279, 1019280, 1019282, 1019283, 1019284, 1019285, 1019286, 1019287, 1019288, 1019289, 1019290, 1019291, 1019292, 1019294, 1102287, 1102288, 1102289, 1102290, 1102291, 1102294, 1102296, 1102297, 1102299, 1102303, 1102304, 1102305, 1102306, 1102308, 1102309, 1107608, 1107610, 1107611, 1107613, 1107615, 1107616, 1107617, 1107618, 1107620, 1107621, 1107626, 1107627, 1107629, 1107630, 1107631, 1454672, 1454673, 1454674, 1601453, 1601454, 1601455, 1601456, 1601458, 1601459, 1601461, 1603598, 1603599, 1603600, 1603601, 1603602, 1603603, 1603605, 1603606, 1603607, 1704431, 1704432, 1704433, 1704434, 1704435, 1704436, 1704438, 1704439, 1704440, 1784663, 1838357, 1838358, 1838359, 1838361, 1838780, 1838781, 1838782, 1856535, 1856536, 1856537, 1856539, 1856540, 1856541, 1856542, 1856543, 1856544, 1927753, 1927754, 1927756, 1927758, 1927759, 2183886, 2183888, 2183889, 2377737, 2377738, 2377742, 2464981, 2512167, 2512170, 2512171, 2887563, 2887564, 2887570, 2887571, 2887575, 2887580, 2887585, 3792363, 3808148, 3808153, 3808154, 3808155, 3808159); 252-13-03 (10885862065834, 0816528, 0816529, 0816530, 0816531, 0816532, 0816533, 0816534, 0816535, 0816537, 0816538, 0816539, 0816540, 0816541, 0816542, 0816543, 0816544, 0816545, 0816546, 0816548, 0816549, 0816550, 0816552, 1103826, 1103827, 1103828, 1103829, 1103830, 1103831, 1103832, 1103833, 1103834, 1177565, 1177567, 1177568, 1177569, 1177570, 1177571, 1177572, 1177573, 1177575, 1177576, 1177578, 1177579, 1177580, 1177581, 1177584, 1177585, 1177586, 1177587, 1177588, 1177589, 1177590, 1177591, 1177592, 1177593, 1177594, 1303849, 1303850, 1303851, 1303852, 1303853, 1303854, 1303855, 1303856, 1303857, 1303858, 1303859, 1303860, 1303861, 1303862, 1303863, 1457350, 1457351, 1457352, 1457353, 1457354, 1548854, 1548855, 1548856, 1548857, 1611609, 1611610, 1611611, 1611612, 1611613, 1611614, 1611615, 1611616, 1611617, 1611618, 1611619, 1611620, 1611621, 1705501, 1705502, 1705503, 1705504, 1705505, 1705506, 1705507, 1705508, 1705509, 1705510, 1705511, 1705512, 1705513, 1807587, 1807589, 1807591, 1807592, 1807593, 1807594, 1807595, 1824050, 1824051, 1824052, 1824054, 1845723, 1845724, 1845725, 1845726, 1845727, 1877151, 1877152, 1877153, 1877154, 1877155, 1897934, 1897935, 1897936, 1897938, 1926313, 1926314, 1926315, 1926316, 1926317, 1992549, 1992550, 1992551, 1992552, 1992553, 2002983, 2002984, 2002986, 2002987, 2049672, 2049673, 2049674, 2049676, 2170671, 2170672, 2170673, 2170675, 2170676, 2170677, 2204946, 2204947, 2204948, 2204949, 2204950, 2204951, 2204952, 2204954, 2204955, 2281013, 2281014, 2281015, 2281016, 2281017, 2281018, 2281019, 2281020, 2281021, 2281022, 2387169, 2387170, 2387173, 2387174, 2387175, 2387176, 2387178, 2387179, 2387180, 2387181, 2387182, 2387183, 2387184, 2387185, 2567178, 2567179, 2567180, 2742356, 2742357, 2742359, 2742360, 2742361, 2742362, 2742363, 2834200, 2834201, 2834202, 2834203, 2834204, 2834205, 2887592, 2887594, 2887595, 2887597, 2887598, 2980252, 2980253, 3124817, 3124818, 3124819, 3124820, 3589948, 3589949, 3589950, 3589951, 3589954, 3589957, 3623858, 3623859, 3623860, 3623861, 3623862, 3623863, 3623864, 3791749, 3791752, 3791753, 4088131, 4088133, 4088134, 4288671, 4288672, 4288673, 4288675, 4288677, 4288679, 4288681, 4288682, 4288683, 4288684, 4288685, 4288686, 4288691); 252-13-04 (10885862065841; 1032302, 1032303, 1032304, 1032305, 1032306, 1032307, 1032308, 1032309, 1032310, 1032311, 1032312, 1032313, 1032314, 1032315, 1032316, 1032317, 1032318, 1032320, 1032322, 1032324, 1032325, 1032326, 1184215, 1184216, 1184217, 1184218, 1184219, 1184220, 1184221, 1184222, 1184223, 1184224, 1184225, 1184227, 1184229, 1184230, 1184231, 1184232, 1184233, 1184234, 1184235, 1184236, 1184237, 1184238, 1406504, 1406505, 1406506, 1406507, 1406508, 1406509, 1406510, 1406511, 1406512, 1406513, 1441232, 1441233, 1441234, 1441235, 1441236, 1453966, 1453967, 1453968, 1453969, 1453970, 1466984, 1466985, 1526558, 1526559, 1544911, 1544912, 1544913, 1544914, 1544915, 1548835, 1548836, 1548837, 1548838, 1548839, 1619057, 1619058, 1619059, 1619060, 1619061, 1619062, 1619063, 1619064, 1619065, 1619066, 1725891, 1725892, 1725893, 1725894, 1725895, 1725897, 1725899, 1725900, 1725901, 1725902, 1725903, 1725904, 1725905, 1725906, 1725907, 1725908, 1725909, 1725910, 1794392, 1794393, 1794394, 1794395, 1794396, 1794397, 1794398, 1794399, 1794400, 1794401, 1794402, 1794403, 1794404, 1894970, 1896281, 1896282, 1896283, 1896284, 1926194, 1926195, 1926196, 1926197, 1926198, 1926199, 1926200, 1926201, 1936083, 1936084, 1936085, 1936088, 1936089, 1936090, 1936091, 1936092, 2100324, 2100325, 2100326, 2100327, 2100328, 2100329, 2100330, 2100332, 2100333, 2257670, 2257671, 2257672, 2257674, 2257675, 2257676, 2257677, 2257678, 2257679, 2329609, 2329610, 2329611, 2329612, 2329613, 2329614, 2329615, 2329616, 2567181, 2567182, 2567183, 2567184, 2567185, 2782405, 2782406, 2782407, 2787081, 2787082, 2787083, 2787084, 2787085, 2845606, 2845607, 2845609, 2845610, 2845612, 2980268, 2980269, 2980270, 2980271, 2980272, 2980273, 2980275, 2980276, 2980277, 2980280, 2980281, 2980282, 2995482, 2995483, 2995484, 2995485, 2995487, 2995488, 3624128, 3624129, 3624130, 3624133, 3624134, 3624137, 3776795, 3776796, 3776797, 3952015, 3952016, 3952017, 3952018, 3952019, 3952020, 3952023, 3952024, 4020002, 4020003, 4020004, 4020006, 4058263, 4058264, 4058265, 4058266, 4058267, 4058268, 4418379, 4418380, 4418383, 4418384, 4418385, 4719663, 4719664, 4719665, 4719666, 4719667, 4719668, 4719669, 4719670, 4719671, 4719672, 4719673); 252-13-05 (10885862065858, 0759432, 0766508, 0766509, 0766510, 0766512, 0766513, 0766514, 0766515, 0766516, 0766517, 0766519, 0766520, 0766522, 0766524, 0766525, 0766526, 0766528, 0766531, 0771768, 0771771, 0771772, 0771773, 0771774, 0771776, 0771781, 0771784, 1332887, 1332888, 1332889, 1332890, 1332891, 1332892, 1332893, 1332894, 1332895, 1332896, 1332897, 1332898, 1332899, 1332900, 1332901, 1332902, 1332904, 1332905, 1332906, 1332907, 1332908, 1332910, 1332911, 1637864, 1637865, 1637866, 1637867, 1637868, 1637869, 1637870, 1637871, 1637873, 1637874, 1637875, 1637876, 1637877, 1637878, 1637879, 1637880, 1637881, 1637882, 1637883, 1637884, 1637886, 1637887, 1637888, 1860543, 1860546, 1860547, 1867301, 1867302, 1867303, 1867304, 1867305, 1867306, 1867307, 1867308, 1867309, 1867310, 1933642, 1933643, 1933644, 1933645, 1933646, 2079592, 2079593, 2079594, 2079595, 2162360, 2162361, 2162362, 2162363, 2162364, 2162365, 2162366, 2162367, 2189315, 2208107, 2208108, 2208109, 2208110, 2208112, 2208113, 2290302, 2290303, 2290305, 2290306, 2345879, 2345880, 2345881, 2345882, 2345883, 2345884, 2387619, 2387620, 2387622, 2387623, 2387624, 2387626, 2387627, 2387628, 2567187, 2730001, 2730002, 2730003, 2730004, 2782332, 2782333, 2782335, 2803106, 2803108, 2803109, 2803110, 2803111, 2803112, 2803113, 2877824, 2877825, 2877827, 2887599, 2887600, 2972268, 2991366, 2991367, 2991369, 2991371, 3563760, 3563762, 3563763, 3669961, 3669962, 3669964, 3730537, 3730538, 3730539, 3786776, 3786777, 3786779, 3786780, 3808133, 3808134, 3808136, 3808137, 3808138, 3808139, 3808141, 3808143, 4039840, 4039843, 4039845, 4279323, 4279327, 4279329, 4279331, 4279333, 4279335, 4279336, 4279338); 252-13-06 (10885862065865; 0764224, 0764226, 0764227, 0764230, 0764231, 0764237, 0764238, 0764241, 0764242, 0764245, 0764247, 1455010, 1689750, 1689751, 1689752, 1717174, 1717175, 1717176, 1717177, 1717178, 1717180, 1717181, 1717183, 1774476, 1774477, 1774478, 1774479, 1774480, 1836619, 1836620, 1836621, 1836622, 1836623, 1850667, 1850668, 1850669, 1850670, 1932007, 1932008, 1932009, 1932010, 2512175, 2742324, 2742325, 2742326, 2742328, 2742329, 2742330, 2742331, 2742333, 2742334, 2742335, 2906755, 2906756, 2906757, 3359313, 3546825, 3546826, 3624172, 3624173, 3624174, 3777081, 3777082, 3777083, 3791763, 3791764, 3791766, 3791767, 3867775, 3867776, 3879613, 3879614, 3906832, 3906833, 3947881, 3971571, 3976717, 3991681, 4005877, 4020007, 4020008, 4046967, 4046968, 4148242, 4148244, 4148245, 4148246, 4148248, 4148249, 4148250, 4148251, 4148252, 4148256, 4148259, 4148262, 4148263, 4148264, 4148265, 4148268, 4148269, 4148271); 252-22-01 (10885862065872; 0754625, 0754626, 0754628, 0754629, 0754631, 0754633, 0754634, 0754635, 0754636, 0754637, 0754638, 0754643, 1235158, 1235159, 1235160, 1235162, 1235164, 1235165, 1235169, 1235171, 1235176, 1235177, 1235178, 1235180, 1235184, 1235185, 1235186, 1235190, 1235191, 1235192, 1235194, 1235195, 1235196, 1235203, 1235204, 1235214, 1235217, 2116253, 2162371, 2162372, 2350994, 2351002, 2758663, 2758665, 2758666, 2758668, 2758672, 2758678, 2759610, 2759611, 2759613, 3664711, 3664712); 252-22-02 (10885862065889; 1102708, 1102713, 1102717, 1102720, 1102721, 1102722, 1102723, 1102725, 1102726, 1102727, 1102728, 1343996, 1343997, 1343998, 1343999, 1344001, 1344002, 1344003, 1344004, 1455015, 1455016, 1455017, 1689735, 1689737, 1689738, 1689739, 1689740, 1689741, 1689742, 1689743, 1689747, 1689748, 1839444, 1839445, 1839446, 1839447, 1839448, 1844107, 1894955, 1894956, 1894957, 2168369, 2168373, 2388628, 2863308, 2863310, 2863311, 2863315, 2863318, 3664722, 3664723, 3664725, 3670106, 3684112, 4221560, 4221567, 4221571); 252-22-03 (10885862065896, 1088653, 1088654, 1088656, 1088657, 1088658, 1088659, 1088662, 1088663, 1088664, 1088668, 1088669, 1249542, 1249545, 1249546, 1249547, 1249548, 1249549, 1249550, 1249551, 1249556, 1249558, 1249559, 1249560, 1249561, 1249563, 1249564, 1649379, 1649380, 1649381, 1649382, 1649384, 1649385, 1649386, 1649387, 1649388, 1649390, 1649391, 1775470, 1775471, 1775472, 1775473, 1775474, 1839858, 1839859, 1839860, 1839861, 1839862, 1858821, 1858822, 1858823, 1858824, 1858825, 1896188, 1896189, 1896191, 1897113, 1897116, 1897117, 1936111, 1936115, 2351066, 2351068, 2351069, 2351070, 2351072, 2351076, 2351079, 2877818, 2877820, 2877821, 3358170, 3358179, 3664737, 3670105, 4221573, 4221575, 4221578, 4221581, 4221582, 4221584, 4221587, 4221588, 4221590, 4221592, 4221595, 4221597, 4221598, 4221599, 4221601); 252-22-04 (10885862065902, 0753334, 0771683, 0771684, 0771685, 0771686, 0771687, 0771688, 0771689, 0771692, 0771693, 0771695, 0771698, 0771699, 0771701, 0771704, 0771705, 1139403, 1139404, 1139405, 1139406, 1139408, 1139409, 1139410, 1139411, 1139412, 1139415, 1139416, 1139417, 1139420, 1139421, 1139423, 1139424, 1416363, 1416364, 1416365, 1416366, 1416367, 1443200, 1443201, 1443203, 1453957, 1453958, 1707020, 1707021, 1707022, 1707024, 1707025, 1707027, 1707028, 1707029, 1772014, 1772015, 1772016, 1772017, 1772018, 1772019, 1822167, 1822168, 1822169, 1822170, 1822171, 1822172, 1822173, 1822174, 1822175, 1822176, 1839528, 1845397, 1845398, 1845400, 1845404, 1845405, 1999773, 1999774, 2058866, 2058867, 2058868, 2058871, 2058873, 2204936, 2204939, 2204942, 2540093, 2540094, 2540095, 2540097, 2540098, 2540099, 2577258, 2796921, 2906758, 2906760, 2906762, 3624089, 3809355, 4093902, 4093904, 4093907, 4093909, 4288641, 4288642, 4288643, 4288644, 4288645, 4288650, 4288651, 4288653, 4288654, 4288660); 252-22-05 (10885862065919; 0764412, 0764413, 0764417, 0764418, 0764422, 0764424, 0764425, 0764426, 0764427, 0764428, 0764429, 0764433, 1161572, 1161573, 1161575, 1237561, 1237562, 1237563, 1237564, 1237565, 1237568, 1237573, 1237575, 1237576, 1237577, 1237579, 1706966, 1706968, 1706969, 1725876, 1725877, 1725878, 1725882, 1725883, 1725884, 1725888, 1725889, 1848135, 1848137, 1848139, 1848140, 1848141, 2300138, 2300139, 2300140, 2300141, 2300142, 2335598, 2335599, 2335601, 2388374, 2388375, 2388377, 2388379, 2388380, 2567191, 2567192, 2713119, 2713120, 2713121, 2713123, 2713125, 2713126, 2782331, 2787092, 2787093, 2787094, 2877823, 2972414, 3543922, 3546846, 3635680); 252-22-06 (10885862065926, 0764201, 0764202, 0764203, 0764218, 0764223, 1722669, 1722673, 1722675, 1722677, 1796929, 1796931, 1796934, 1796936, 1838482, 1838483, 1846139, 1846140, 1846141, 1846143, 2165648, 2165649, 2165652, 2388623, 2388624, 2388625, 2388626, 2742343); 252-23-01 (10885862065933; 0757809, 0757810, 0757811, 0757813, 0757816, 0757817, 0757823, 0757825, 1139427, 1139428, 1139430, 1139431, 1139433, 1139435, 1139436, 1139438, 1139440, 1139442, 1139443, 1139445, 1139446, 1139448, 1458481, 1704859, 1765611, 1765612, 1765614, 1779510, 1779511, 1779512, 1779513, 1779515, 1779518, 1927737, 1927738, 1927739, 1927747, 2566828, 2793214, 2793216, 2793218, 2972411, 3624029, 3635664, 3664731, 3677964, 3677965, 3677970, 3677971); 252-23-02 (10885862065940; 1105678, 1105679, 1105682, 1105683, 1105685, 1105686, 1105688, 1105689, 1105692, 1105693, 1105694, 1105700, 1105701, 1416341, 1416343, 1416344, 1458477, 1637148, 1637149, 1637150, 1637151, 1637906, 1637908, 1637909, 1637910, 1637911, 1637912, 1637913, 1637916, 1637917, 1769924, 1769925, 1769926, 1769927, 1769929, 1769930, 1769931, 1839863, 1845257, 1845258, 1845259, 1845261, 1845263, 1845264, 1905140, 1905141, 1905142, 1905143, 1905144, 1927764, 2059085, 2059089, 2059091, 2059094, 2388367, 2388371, 2787080, 3624166, 3624167, 3624168, 3699141, 3699142, 4211364, 4211370, 4211384); 252-23-03 (10885862065957; 0742241, 0742243, 0742245, 0742253, 0742254, 0742255, 0742256, 0742257, 0742258, 0742259, 0742264, 0742266, 0742269, 0779777, 1157151, 1157152, 1157153, 1157154, 1157156, 1157158, 1157160, 1157161, 1157162, 1157164, 1157165, 1157166, 1157167, 1157168, 1157172, 1157173, 1443148, 1443150, 1443151, 1443152, 1701768, 1701769, 1701771, 1701772, 1701773, 1701774, 1701776, 1701777, 1741523, 1741524, 1741526, 1741527, 1741528, 1741529, 1741530, 1741531, 1741532, 1741533, 1741534, 1741535, 1741536, 1741537, 1741538, 1741539, 1741540, 1741541, 1741542, 1741543, 1741544, 1741545, 1741546, 1855733, 1855735, 1855736, 1855737, 1896405, 1896406, 1896407, 1896408, 1896409, 1926202, 1926203, 1926204, 1926205, 1926206, 2119809, 2119810, 2119811, 2119812, 2163600, 2163604, 2163607, 2163608, 2282405, 2282406, 2388613, 2388615, 2388619, 2388620, 2388621, 2829279, 2829282, 2965411, 2965414, 3520578, 3520579, 3520580, 3589940, 3623850, 3623851, 3792532, 4058262, 4148277, 4148278, 4148281, 4148283, 4148284, 4148285, 4148286, 4148287, 4148289, 4148290, 4148291, 4148292, 4148293, 4148294, 4148295, 4148296, 4148299, 5839564); 252-23-04 (10885862065964; 1141051, 1141052, 1141055, 1141056, 1141057, 1141058, 1141059, 1141061, 1141062, 1141063, 1141064, 1141065, 1141066, 1141067, 1141068, 1141070, 1141071, 1141072, 1141073, 1141074, 1434898, 1434899, 1434900, 1434901, 1453962, 1453963, 1453964, 1632745, 1632746, 1632749, 1632750, 1632751, 1632753, 1632754, 1632757, 1632759, 1706960, 1706961, 1706962, 1706963, 1709948, 1709949, 1709950, 1709951, 1709952, 1777266, 1839529, 1839530, 1839531, 1839532, 1839533, 1844761, 1844762, 1844763, 1844764, 1858816, 1858817, 1858818, 1858819, 1858820, 1923303, 1923304, 1923305, 1923306, 1923307, 1923308, 1923309, 1923311, 1941007, 1941008, 1941009, 2351045, 2351047, 2351048, 2351049, 2351056, 2351057, 2351058, 2351059, 2351060, 3589945, 3670112, 4052828, 4052832, 4052834, 4325986, 4325988); 252-23-05 (10885862065971; 0759431, 0766124, 0766126, 0766130, 0766131, 0766133, 0766134, 0766136, 0766137, 0766139, 0766141, 0766142, 0766146, 1159234, 1159235, 1159236, 1159237, 1159247, 1159248, 1159249, 1159250, 1441237, 1441238, 1441239, 1441240, 1453953, 1453954, 1453955, 1453956, 1741361, 1741364, 1741365, 1741366, 1741368, 1741369, 1741370, 1741371, 1741374, 1741379, 1844814, 1844815, 1844816, 1932011, 1932013, 1932014, 1932015, 2243133, 2243134, 2243137, 2243138, 2243140, 2243141, 2345641, 2345642, 2345643, 2345644, 2345645, 2345648, 2345649, 2345650, 2345651, 2502108, 2566830, 2742341, 2782327, 2782328, 2803115, 2803122, 3546765, 3546766, 3623857); 252-23-06 (10885862065988; 0763507, 0763510, 0763511, 0763512, 0763513, 0763514, 0763517, 0763523, 0763524, 1725300, 1725301, 1725302, 1725303, 1725304, 1725305, 1725306, 1725308, 1725309, 1725310, 1725312, 1725313, 1725314, 1725315, 1848127, 1848129, 2536001, 2536003, 2536004, 2536007, 2536009, 2536010, 2566836, 2566837, 2566838, 2787100, 2787101, 2829284, 3808171, 3808172, 3808176);
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0019-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0020-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0021-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0022-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0023-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0024-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0025-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0026-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0027-2022 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.