Z-0024-2022Class II
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line...
Exactech, Inc. / initiated 2021-08-30 / Open, Classified / root cause: manufacturing process
Exactech, Inc. began a recall of Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing... 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-0024-2022
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Exactech, Inc.
- Product
- Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
- Product code
- HSN Prosthesis, Ankle, 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
- 2,217 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
- a. Item Number (Device Identifier; Serial number(s)): 350-21-01 (10885862276216; 4833710, 4833714, 4833715, 4833717, 4833723, 5188005, 5188007, 5188008, 5188009, 5188011, 5188013, 5188015, 5188017, 5188021, 5188022, 5188023, 5939820, 5939826, 5939831, 5939832, 5939833, 5939835, 5939836, 5939837, 5939838, 5939839, 5939840, 5939841, 5939842, 5939844, 5939845, 5939846, 6015553, 6015554, 6015556, 6015557, 6015560, 6015563, 6015566, 6015567, 6015569, 6396486, 6396489, 6396493, 6396495, 6396500, 6396504, 6396505, 6489379, 6489381, 6489382, 6489384, 6489386, 6606659, 6606667, 6606678, 6860126, 6860127, 6900582, 6900585, 6900588, Z060698, Z060703, Z060715, Z064072, Z064105, Z064107); 350-21-02 (10885862276223; 4536664, 4536665, 4536666, 4536668, 4536669, 4536670, 4536672, 4842955, 4842956, 4842957, 4842958, 4842959, 5184645, 5184647, 5184648, 5184649, 5184651, 5184652, 5184653, 5184654, 5184656, 5184657, 5184658, 5855814, 5855815, 5855816, 5855819, 5855820, 5855823, 5855824, 5855825, 5855826, 5855827, 5855828, 5855829, 5855830, 6240459, 6240461, 6240463, 6240464, 6240467, 6259881, 6259882, 6259884, 6259885, 6259888, 6356551, 6356552, 6356561, 6356562, 6356564, 6356566, 6356568, 6356569, 6356570, 6395847, 6395848, 6395852, 6395854, 6395855, 6395856, 6395858, 6395860, 6489055, 6489056, 6489059, 6489063, 6489065, 6489066, 6489069, 6489070, 6489071, 6489072, 6489073, 6583838, 6583839, 6583842, 6583843, 6583844, 6583845, 6583846, 6583849, 6583852, 6583853, 6583855, 6583857, 6730685, 6730688, 6730690, 6730696, 6730697, 6899729, 6899744, 6899751, Z068705, Z075029, Z075042); 350-21-03 (10885862276230; 4536738, 4536739, 4536740, 4536741, 4536742, 4536743, 4536745, 4536746, 4841023, 4841024, 4841025, 5184662, 5184663, 5184665, 5184666, 5184668, 5184669, 5184671, 5184672, 5184673, 5184674, 5184675, 5184678, 5184679, 5184680, 5221264, 5221265, 5221266, 5221267, 5221268, 5221269, 5221270, 5221272, 5221273, 5221274, 5221275, 5221276, 5940499, 5940500, 5940502, 5940507, 5940511, 5940516, 5940517, 5940518, 5940519, 5940520, 6039207, 6039208, 6039210, 6039212, 6039213, 6039214, 6039215, 6039218, 6039220, 6039221, 6039222, 6039223, 6039225, 6173447, 6173449, 6173450, 6173451, 6173452, 6173455, 6173456, 6173458, 6173459, 6173460, 6173462, 6173463, 6173464, 6173465, 6372717, 6372718, 6372719, 6372720, 6372721, 6372726, 6372727, 6372729, 6372730, 6372735, 6489128, 6489129, 6489131, 6489133, 6489134, 6489135, 6489136, 6489137, 6489145, 6489146, 6535721, 6535723, 6535724, 6535729, 6535730, 6535731, 6535732, 6535734, 6742242, 6742248, 6742249, 6742250, 6742251, 6742253, 6742255, 6742259, 6811600, 6811611, 6811612, 6900322, Z074962, Z074972, Z074984, Z075184); 350-21-04 (10885862276247; 4537204, 4537205, 4537206, 4537207, 4537212, 4750991, 5184539, 5184541, 5184543, 5184548, 5184550, 5184553, 5184554, 5184557, 5240718, 5240721, 5240727, 5240728, 5909332, 5909335, 5909337, 5909338, 5909344, 5909350, 5954808, 5954810, 5954815, 5954820, 6356463, 6356464, 6356466, 6356471, 6356472, 6356473, 6356477, 6489076, 6489081, 6489083, 6489093, 6758223, 6758226, 6758227, 6856945, 6856949, 6995782, Z068655); 350-21-11 (10885862276254; 4536710, 4536711, 4536714, 4536715, 4536716, 4536717, 4536718, 4704930, 4704938, 4704939, 4704940, 4704944, 4704945, 4704949, 4704951, 4704956, 4704957, 4787630, 4787631, 5184636, 5184639, 5184640, 5184643, 5231854, 5231855, 5231858, 5231860, 5969127, 5969128, 5969129, 5969132, 6356520, 6356523, 6489037, 6489045, 6489052); 350-21-12 (10885862276261; 4704789, 4771382, 4771383, 4771384, 4771387, 4771388, 5184684, 5184689, 5184690, 5184691, 5184697, 5184698, 5237420, 5237421, 5237422, 5237423, 5237424, 5237426, 5237430, 5237431, 5237432, 5939798, 5939801, 5939802, 5939803, 5939807, 5939810, 6356669, 6356670, 6356671, 6356672, 6356677, 6356680, 6356681, 6356683, 6356684, 6489360, 6489363, 6489365, 6489366, 6489369, 6489370, 6489372, 6598979, 6598980, 6598983, 6598985, 6843245, 6843247, 6843261, 6883796, Z058384, Z074986, Z074999); 350-21-13 (10885862276278; 4704790, 4771176, 4977232, 4977233, 4977235, 5181919, 5181921, 5181923, 5181926, 5181927, 5181931, 5181932, 5181934, 5222348, 5222349, 5222352, 5222355, 5222356, 5222357, 5222358, 5908535, 5908536, 5908537, 5908540, 5908541, 5908542, 5908544, 5908548, 5908549, 6061322, 6061327, 6323250, 6323261, 6395423, 6395424, 6395426, 6395428, 6488292, 6488297, 6488301, Z075109, Z075175); 350-21-14 (10885862276285; 4746009, 5184848, 5184851, 5184852, 5184853, 5184858, 5184860, 5184864, 5184865, 6143314, 6143323, 6143326, 6143329, 6143331, 6395394, 6395395, 6719894, Z076042); 350-21-21 (10885862276292; 4676330, 4676331, 4676332, 4676333, 4676334, 4676335, 4676336, 4676338, 4676345, 4676347, 4676351, 4676355, 5185107, 5185108, 5185110, 5185111, 5185113, 5185114, 5185117, 5185118, 5185119, 5245298, 5906409, 5906414, 5938419, 5938422, 5938424, 5938428, 6356532, 6356533, 6356537, 6356542, 6356549, 6486889, 6486890, 6486896, 6804245, 6900926); 350-21-22 (10885862276308; 4750965, 4771177, 5184866, 5184867, 5184870, 5184872, 5184873, 5184874, 5184878, 5184879, 5184880, 5184881, 5184883, 5876458, 5876461, 5876467, 6142807, 6142808, 6142811, 6142819, 6142825, 6411781, 6411784, 6428914, 6428917, 6428918, 6435219, 6435225, 6621519, 6621521, 6621524, 6621536, 6883664, 6883667, 6883671, 6959803, Z059779); 350-21-23 (10885862276315; 4771244, 4866126, 4866127, 4866129, 5172559, 5172560, 5172565, 5172566, 5172567, 5172569, 5172570, 5172572, 5172574, 5172577, 5172580, 5172581, 5172582, 5172583, 5172584, 5172588, 5172589, 5989847, 5989848, 5989849, 5989850, 5989853, 5989859, 5989861, 6408952, 6408954, 6408958, 6408959, 6408960, 6487891, 6487893, 6487895, 6487896, 6487897, 6487900, 6487902, 6487908, 6487909, 6644822, 6644825, 6644826, 6644831, 6644834, 6644835, 6644838, Z058458, Z058462, Z060686); 350-21-24 (10885862276322; 4536720, 4536721, 4536723, 4536724, 5185120, 5185127, 5185129, 5185132, 5185133, 5185134, 5185135, 5245294, 5245296, 5882353, 5882355, 5882358, 5882364, 5882365, 6142592, 6142601, 6142602, 6142605, 6142607, 6142608, 6396151, 6396156, 6851740, Z058435); 350-21-41 (10885862293213; 5181205, 5181206, 5181209, 5181210, 5181211, 5181212, 5181214, 5181215, 5181217, 5181218, 5181219, 5181222, 5954729, 5954730, 5954736, 5954745, 6409727, 6747749, 6747752, 6897935); 350-21-42 (10885862293220; 5184830, 5184831, 5184833, 5184837, 5184838, 5184839, 5184840, 5184844, 5184845, 5201342, 5201345, 5201349, 5909253, 5940479, 5940481, 5940482, 5940484, 5940487, 5940493, 5940495, 6143274, 6143276, 6143277, 6143282, 6143285, 6143286, 6143289, 6143292, 6396172, 6540417, 6540421, 6911569, Z059753); 350-21-43 (10885862293237; 5102165, 5102166, 5102171, 5102173, 5102174, 5102178, 5102179, 5102180, 5102183, 5230186, 5230190, 5230192, 5230196, 5230197, 5230199, 5230200, 5230203, 5912834, 5912837, 5912838, 5912840, 5912844, 5912846, 5912848, 6015723, 6015725, 6015728, 6395893, 6395900, 6571764, 6571775, 6860987, 6913035, Z077359); 350-21-44 (10885862293244; 5181165, 5181177, 5181178, 5967776, 5967781, 6325734, 6398023, 6424762, 6709425); 350-21-61 (10885862293374; 5185137, 5185147, 5909303); 350-21-62 (10885862293381; 6143359, 6143360, 6143368, 6143370, Z060582); 350-21-63 (10885862293398; 4733268, 5185157, 6487566); 350-21-64 (10885862293404; 5185168, 6143340, 6143348, 6488098); 350-22-01 (10885862276339; 4681920, 4681922, 4681923, 4681925, 4681927, 4681928, 4681930, 4681931, 4681932, 4681933, 4681934, 4681935, 4681937, 4681938, 4681940, 4681943, 4681945, 4681946, 4681948, 4681949, 5139951, 5139952, 5139953, 5139955, 5139956, 5139962, 5139963, 5139968, 5139970, 5139971, 5876391, 5876392, 5876393, 5876396, 5876398, 5876399, 5876403, 5876407, 5876412, 6127984, 6127985, 6127987, 6127993, 6127995, 6127997, 6128000, 6128003, 6395402, 6395406, 6395407, 6395410, 6395417, 6487092, 6487093, 6487094, 6487095, 6487097, 6487100, 6487102, 6487103, 6487106, 6487107, 6487108, 6487110, 6720137, 6720139, 6720142, 6720145, 6720146, 6720150, 6720152, 6720153, 6907877, 6907886, 6907887, 6907888, 6907892, 6907896, 6907899, 6907901, 6911587, 6911594, Z073322, Z073329); 350-22-02 (10885862276346, 4771234, 4771235, 4771236, 4771237, 4771238, 4771239, 4771240, 5181224, 5181225, 5181228, 5181229, 5181234, 5181235, 5181236, 5181237, 5181238, 5181239, 5181240, 5181241, 5181242, 5181244, 5245289, 5245290, 5245291, 5245292, 5245293, 5985462, 5985463, 5985464, 5985466, 5985468, 5985470, 5985471, 5985472, 5985473, 5985474, 5985475, 5985476, 5985477, 5985478, 5985480, 5985481, 6048026, 6048027, 6048028, 6048030, 6048031, 6067781, 6067782, 6067783, 6067785, 6067786, 6067787, 6067788, 6067790, 6067792, 6259896, 6259897, 6308445, 6308446, 6308447, 6308448, 6308451, 6308452, 6308454, 6308458, 6411977, 6411978, 6411979, 6411980, 6411981, 6411983, 6411984, 6411985, 6411989, 6434808, 6434811, 6434812, 6434813, 6434814, 6434816, 6434817, 6434818, 6434820, 6434821, 6434822, 6434823, 6434824, 6532890, 6532891, 6532895, 6532898, 6532899, 6532900, 6532902, 6532903, 6532904, 6532907, 6535639, 6535641, 6535643, 6535644, 6535645, 6535646, 6535649, 6535650, 6535651, 6535654, 6535657, 6758072, 6758073, 6758074, 6899905, 6899911, 6899914, 6899919, Z071104, Z071116, Z071136, Z076051); 350-22-03 (10885862276353; 4884296, 4884297, 4884298, 4884299, 5185183, 5185184, 5185187, 5185189, 5185190, 5185191, 5185192, 5185194, 5185195, 5185196, 5256071, 5256072, 5256073, 5256074, 5256075, 5256077, 5256078, 5256079, 5256080, 5938438, 5938439, 5938440, 5938441, 5938442, 5938447, 5938448, 5938451, 5938452, 5938453, 5938454, 5938456, 5938457, 5988014, 5988015, 5988016, 5988018, 5988019, 5988020, 5988022, 5988023, 5988025, 5988026, 5988027, 5988029, 5988030, 6252633, 6252634, 6252636, 6252638, 6252640, 6252641, 6285206, 6285207, 6285208, 6285210, 6285211, 6285212, 6285213, 6285215, 6340621, 6340630, 6340631, 6340632, 6340635, 6395438, 6395439, 6395440, 6395441, 6395444, 6395446, 6395451, 6395456, 6395457, 6482649, 6482650, 6482656, 6482662, 6482664, 6482665, 6509210, 6509214, 6509215, 6509216, 6509218, 6509219, 6509220, 6509223, 6509224, 6509227, 6683471, 6683474, 6683475, 6683477, 6683482, 6683485, 6683488, 6683492, 6718699, 6718707, 6718715, 6718716, 6852366, 6852367, 6852368, 6852375, 6852377, 6852379, 6853420, 6853427, 7010354, Z072696, Z073295); 350-22-04 (10885862276360; 5181310, 5181313, 5181314, 5181315, 5181317, 5181323, 5181327, 5262727, 5262729, 5262730, 5262731, 5262733, 5262735, 5262736, 5262737, 5907662, 5907666, 5907670, 5907671, 5907672, 5907673, 5907674, 5907676, 5967477, 5967482, 5967487, 5967488, 5967489, 5967491, 5967493, 5967494, 5967495, 6337400, 6337402, 6337406, 6337407, 6482499, 6502574, 6502576, 6502580, 6502586, 6502589, 6846082, 6846088, Z058442, Z058443, Z075357); 350-22-11 (10885862276377; 4703168, 4703171, 4703174, 4703177, 4703178, 4703179, 4703180, 4703183, 4703184, 4703187, 4703188, 4703190, 4703191, 4703192, 4703193, 4703194, 4703195, 4703196, 4703197, 4857844, 4857845, 4857846, 4857847, 5181328, 5181331, 5181336, 5181337, 5181338, 5181339, 5181341, 5181343, 5181345, 5954756, 5954758, 5954759, 5954761, 5954765, 6137105, 6137106, 6137115, 6137119, 6137121, 6372459, 6372468, 6372471, 6372474, 6372475, 6487131, 6487137, 6898086, Z075079); 350-22-12 (10885862276384; 4704788, 4771243, 5181347, 5181348, 5181349, 5181351, 5181352, 5181353, 5181354, 5181355, 5181356, 5181359, 5181360, 5181363, 5181364, 5193990, 5193991, 5193993, 5193995, 5193996, 5193997, 5193998, 5193999, 5194001, 5194002, 5194003, 5194004, 5882202, 5882208, 5882209, 5882210, 5882211, 5882212, 5882214, 5882215, 5882216, 5882218, 5882219, 5882282, 5882283, 5882284, 5882285, 5882286, 5882292, 5882295, 6356685, 6356691, 6356694, 6356695, 6356703, 6428946, 6489020, 6489021, 6489025, 6489026, 6489029, 6489031, 6502624, 6502629, 6502633, 6502634, 6683224, 6683231, 6898077, 6970223, 6970236, Z075900); 350-22-13 (10885862276391; 4771241, 4771242, 5120877, 5120882, 5120885, 5120886, 5120887, 5120889, 5204239, 5204240, 5204242, 5204244, 5204245, 5204247, 5204248, 5204250, 5204251, 5204252, 5939735, 5939741, 5939742, 5939744, 5939745, 5939746, 5939748, 5939749, 5939750, 5939751, 5939752, 5939753, 5939754, 6136641, 6136646, 6136649, 6136650, 6136651, 6428891, 6428893, 6489094, 6489097, 6489109, 6489124, 6489125, 6856921, 6856930, 6856931, Z058368, Z058370, Z074916); 350-22-14 (10885862276407; 5181368, 5181373, 5181374, 5181376, 5181380, 5181381, 5181383, 5906479, 5967548, 5967552, 5967553, 5967560, 5967564, 5967567, 6174579, 6174584, 6174589, 6569281, 6569289); 350-22-21 (10885862276414; 4703140, 4703141, 4703142, 4703143, 4703144, 4703147, 4703148, 4703149, 4703152, 4703154, 4703155, 4703156, 4703158, 4703160, 4703162, 4703163, 4703165, 4703167, 5185215, 5185216, 5185219, 5185221, 5185223, 5185225, 5185228, 5214261, 5214264, 5214265, 5939780, 5939788, 5939789, 6259901, 6395459, 6395470, 6591152, 6591161, 6591163); 350-22-22 (10885862276421; 4748658, 4771389, 5120893, 5120894, 5120895, 5120897, 5120898, 5120899, 5120900, 5120901, 5120902, 5120906, 5120907, 5120909, 5120912, 5120913, 5120914, 5120915, 5241242, 5241243, 5241244, 5241245, 5241246, 5241247, 5241248, 5241249, 5241250, 5241251, 5241252, 6015770, 6015777, 6015788, 6395920, 6487170, 6487175, 6487177, 6487179, 6487180, 6487181, 6742061, 6742065, 6742069, 6911514, Z075188, Z075281); 350-22-23 (10885862276438; 4771390, 4771392, 4771393, 4771394, 5181291, 5181294, 5181295, 5181296, 5181297, 5181299, 5181300, 5181301, 5181302, 5181303, 5181304, 5181305, 5181308, 5880510, 5880511, 5880514, 5880525, 5938089, 5938090, 5938091, 5938093, 5938096, 5938097, 5938099, 5938103, 5938105, 5938106, 5938107, 6395828, 6395831, 6395833, 6395837, 6395843, 6411724, 6411725, 6411726, 6411729, 6411730, 6411731, 6411735, 6411738, 6411741, 6506227, 6506228, 6506231, 6506234, 6506235, 6506239, 6506242, 6506243, 6734441, 6734442, 6734444, 6734447, 6734454, 6734455, 6870162, 6870183, 6870188, Z075253); 350-22-24 (10885862276445; 5181451, 5181453, 5181455, 5181458, 5181459, 5181464, 5232860, 5232861, 5232864, 5232867, 5232869, 5232870, 5232871, 5232874, 5232876, 5232877, 5907747, 5907751, 5939721, 5939727, 5939732, 6395493, 6395506, 6487126, 6487130, 6822884, 6822896, Z060416, Z069324); 350-22-41 (10885862293251; 5187946, 5187954, 5187956, 5907658, 5954768, 5954774, 5954779, 6396518, 6396521, 6489006); 350-22-42 (10885862293268; 5185783, 5185787, 5185788, 5185789, 5185790, 5185793, 5185794, 5185795, 5185799, 5185801, 5201264, 5201265, 5201266, 5201272, 5201273, 5201275, 5201276, 5201278, 5938401, 5938402, 5938404, 5938409, 5938411, 5938416, 6391264, 6483678, 6483684, 6483687, 6520721, 6520724, 6520725, 6520732, 6520733, 6520737, 6738668, 6738674, 6898015, 6898023, Z070796, Z070802); 350-22-43 (10885862293275; 5122629, 5122632, 5122635, 5122637, 5122638, 5122643, 5122645, 5122646, 5122648, 5260636, 5260638, 5260642, 5260643, 5260645, 5883315, 5883316, 5883324, 5940026, 5940027, 5940029, 5940033, 5940037, 5940038, 5940039, 5940041, 5940042, 6273558, 6273559, 6273562, 6273568, 6273570, 6412019, 6579440, 6579442, 6579443, 6579448, 6886404, Z060757); 350-22-44 (10885862293282; 5185203, 5185206, 5185209, 5967508, 5967510, 6417987, 6683339, 6737449); 350-22-62 (10885862293428; 5181465, 5181473, 5181484, 5948972, 5948990); 350-22-63 (10885862293435; 5181395, 5906439, 5906440, 6409703, 6409711, 6409712, Z077335); 350-22-64 (10885862293442; 5181406, 5181407, 5181414, 5181421, 5975072, 5975080); b. Item Number (Device Identifier; Serial number(s)): 350-41-01 (10885862276452; 4851797, 4851798, 4851799, 4851800, 4964108, 4986270, 5194348, 5194350, 5194353, 5194356, 5194357, 5194358, 6409670, 6506001, 6506009, 6857644, 6857646, 6857652); 350-41-02 (10885862276469; 4850102, 4850103, 4850104, 4850105, 4963948, 4963951, 5194275, 5194276, 5194277, 5194279, 5194280, 5194281, 5194282, 5194283, 5194285, 5194286, 5194287, 5194288, 5194289, 5194290, 5194291, 5194292, 5865068, 5865072, 5865073, 5865076, 5865081, 5865086, 5865087, 5865089, 6330721, 6330728, 6330732, 6507180, 6507186, 6507198, 6592234, 6592235); 350-41-03 (10885862276476; 4851814, 4851816, 4963859, 4963860, 4963862, 5181425, 5181426, 5181428, 5181430, 5181432, 5181433, 5181434, 5181435, 5181436, 5181438, 5181440, 5181441, 5181443, 5181444, 6138428, 6409639, 6409640, 6409644, 6409647, 6409650, 6409651, 6409652, 6409658, 6535259, 6535265, 6535268, 6900013); 350-41-04 (10885862276483; 4851782, 4851783, 4851784, 4913716, 5193807, 5193811, 5193813, 5193819, 6143103, 6143110, 6506247, 6506251, 6506260, 6506262, 6506263); 350-41-05 (10885862302038; 5192099); 350-41-11 (10885862276490; 4851670, 4851671, 4851672, 4963858, 5194262, 5194265, 5194268, 5194274, 6506369, 6506380); 350-41-12 (10885862276506; 4850106, 4850107, 4850108, 4850109, 4913690, 4913691, 4913693, 5194293, 5194294, 5194297, 5194304, 5194307, 6505962, 6505963, 6505968, 6566991, 6566994, 6566999, 6567000); 350-41-13 (10885862276513; 4850078, 4850079, 4850080, 4850081, 4963842, 5194329, 5194331, 5194333, 5194334, 5194336, 5194338, 5194339, 5194342, 5194345, 6141325, 6141326, 6141329, 6439029, 6439031, 6439041, 6825226); 350-41-14 (10885862276520; 4851603, 4913723, 4913724, 4913725, 5193794, 5193795, 5193798, 5193806, 6143269, 6776618, 6776626); 350-41-15 (10885862302045; 5194254); 350-41-21 (10885862276537; 4850098, 4850099, 4850100, 4963849, 4963850, 4963852, 5205336, 5205342, 5205346, 5205347, 6506333, 6506347); 350-41-22 (10885862276544; 4851637, 4851638, 4851639, 4851640, 4930455, 4930456, 4930458, 4930460, 5250981, 5250983, 5250985, 5250986, 5250987, 5250988, 6143140, 6507141, 6922888, Z081039); 350-41-23 (10885862276551; 4850110, 4850111, 4850112, 4913660, 4913661, 4913662, 4913663, 5194236, 5194237, 5194239, 5194240, 5194246, 5194247, 5194248, 5194250, 5194251, 5194252, 6141292, 6141293, 6466622, 6504528, 6504529, 6775088, 6775098, 6775102); 350-41-24 (10885862276568; 4850094, 4850095, 4850096, 4850097, 4963769, 4963772, 5184563, 5184566, 5184568, 5184571, 5184576, 6141203, 6505950, 6505958); 350-41-25 (10885862302052; 5194176, 5194177); 350-41-41 (10885862293534; 4851727, 4963764, 4963765, 5194226, 5194231); 350-41-42 (10885862293541; 4850090, 4850091, 4850092, 4850093, 4963759); 350-41-43 (10885862293558; 4851761, 4851763, 4963777, 4963778, 4963780, 5194201, 5194203, 5194206, 5194212, 5194215, 5194216, 6143085, 6506501); 350-41-44 (10885862293565; 4851693, 4963661, 4963662, 5193851, 5193852, 6139778, 6139786); 350-41-45 (10885862302076; 5194180); 350-41-61 (10885862293695; 4851597, 4851598); 350-41-62 (10885862293701; 4851588, 4963649, 5194100); 350-41-63 (10885862293718; 4851593, 4851594); 350-41-64 (10885862293725; 4851599, 4851600, 5194096); 350-41-65 (10885862302090, 5194116, 5194118); 350-42-01 (10885862276575; 4851765, 4851766, 4851767, 4851768, 4962062, 4962065, 4962067, 5181941, 5181942, 5181945, 5181948, 5181949, 5181951, 5181955, 5181956, 5181957, 6504541, 6504544, 6504545, 6504547, 6504548, 6504550, 6813572, 6813577, 7009630); 350-42-02 (10885862276582; 4847130, 4847131, 4847132, 4962961, 4962964, 4962965, 5194138, 5194139, 5194140, 5194141, 5194143, 5194145, 5194147, 5194149, 5194150, 5194152, 5194153, 5194155, 5910497, 5910507, 6442342, 6442348, 6442351, 6506023, 6506024, 6506029, 7011500); 350-42-03 (10885862276599; 4847207, 4847208, 4847209, 4847210, 4863354, 4863355, 4863356, 4863357, 4863358, 4863359, 4863360, 5229805, 5229806, 5229807, 5229809, 5229812, 5229813, 5229815, 5229817, 5229819, 5229820, 5229821, 5229822, 6070811, 6070812, 6356277, 6356281, 6356282, 6356284, 6356286, 6356288, 6356289, 6356292, 6356293, 6356295, 6570281, 6570284, 6570291, 6570292, 6570297, 6862327, 6862328, 6862329, 6862332, 6862333); 350-42-04 (10885862276605; 4847172, 4847173, 4847174, 4914356, 4914359, 4959353, 4959356, 4959357, 5245932, 5245934, 5245935, 5245936, 5245938, 5245939, 5245942, 5245944, 6095443, 6095450, 6095453, 6095455, 6505375, 6505376, 6505383, 6505384, 6505385, 6505390, 6505392); 350-42-05 (10885862302106; 5192871); 350-42-11 (10885862276612; 4851829, 4851830, 4851831, 4851832, 4962030, 5192065, 5192067, 5192070, 5192071, 5192075, 5192077, 6143134, 6506128, 6506130, 6981225); 350-42-12 (10885862276629; 4847136, 4847137, 4914322, 4914323, 4914325, 4959360, 4959361, 4959363, 4959364, 5234643, 5234651, 5234652, 5234654, 6138480, 6138483, 6138489, 6505702, 6505703, 6505708, 6505709, 6505711, 6861040, 6861055); 350-42-13 (10885862276636; 4851580, 4851581, 4851582, 4959342, 4959346, 5181960, 5181961, 5181963, 5181964, 5181965, 5181966, 5181967, 5181970, 5181971, 5181972, 5181974, 5181975, 5181976, 5181977, 6143249, 6143253, 6456685, 6456692, 6456695, 6456703, 6591960, 6591961, 6591962, 6982233, 6982235, 6982236, Z081206, Z081219, Z081222); 350-42-14 (10885862276643; 4851584, 4851586, 4914362, 4914363, 4914364, 4914365, 4959348, 4959350, 5247865, 5247867, 5247870, 5247876, 6095825, 6095826, 6095835, 6458504, 6504558, 6504563, 6795422, 6795424); 350-42-15 (10885862302113; 5192877, 5192879); 350-42-21 (10885862276650; 4851469, 4851470, 4851471, 4851472, 4959335, 5192816, 5192820, 5192822, 6143099, 6143102, 6505394, 6505399, 6505404, 6505407, 6505409, 6505410); 350-42-22 (10885862276667; 4851477, 4851478, 4851479, 4851480, 4963995, 5192850, 5192851, 5192852, 5192853, 5192854, 5192855, 5192856, 5192857, 5192859, 5192862, 5192864, 5192865, 5192866, 6013085, 6013087, 6013088, 6504632, 6504637, 6504640, 6504641, 6900864); 350-42-23 (10885862276674; 4850086, 4850087, 4850088, 4850089, 4915608, 4915609, 4915610, 4959366, 4959367, 4959368, 4959369, 4959370, 5247851, 5247852, 5247853, 5247855, 5247857, 5247861, 6140620, 6140624, 6140626, 6505022, 6505024, 6505035, 6505037); 350-42-24 (10885862276681; 4851474, 4851476, 4964102, 4964105, 4964106, 5192835, 5192837, 5192841, 5192842, 6505078, 6505084, 6505086, 6505090, 6505093, 6505094, 6505095); 350-42-25 (10885862302120; 5192873); 350-42-41 (10885862293572; 4851484, 4964051, 4964054, 4964055, 6140502, 6505414, 6505426, 6505429); 350-42-42 (10885862293589; 4851486, 4851487, 4851488, 4964095, 4964096, 4964097, 5192764, 5192765, 5192771, 5192777, 6143120, 6566946, 6566948); 350-42-43 (10885862293596; 4851501, 4851502, 4851503, 4851504, 5192747); 350-42-44 (10885862293602; 4850481, 4850482, 4850484, 4964061, 5192734); 350-42-45 (10885862302144; 5192492); 350-42-61 (10885862293732; 4850491, 4964127, 4964130); 350-42-62 (10885862293749; 4850477, 4850479, 5193940); 350-42-63 (10885862293756; 4850485, 4850486, 4850488, 5194360, 6138511); 350-42-64 (10885862293763; 4964131, 4964133, 5194389, 5194394); 350-42-65 (10885862302168, 5192508);
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.