Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding art

Summary

The FDA issued a Class II for Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the by I.T.S. GmbH. Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instruct.

Details

Product Description

Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-Column Plate; Article Numbers: 21216-10, 21216-12, 21217-10, 21217-12. 4. Cancellous Screw; Article Numbers: 30591-36, 30591-70, 30591-75, 30591-80, 30591-85, 30591-90. 5. Cancellous Screw, Locking; Article Numbers: 37422-12-N, 37422-14-N, 37422-16-N, 37422-18-N, 37422-20-N, 37422-22-N, 37422-24-N, 37422-26-N, 37422-28-N, 37422-30-N, 37422-32-N, 37422-34-N, 37422-36-N, 37422-38-N, 37422-40-N, 37422-42-N, 37422-44-N, 37422-46-N, 37422-48-N, 37422-50-N, 37422-55-N, 37422-60-N, 37422-65-N, 37422-70-N, 37422-75-N, 37422-80-N, 37422-85-N, 37422-90-N, 37422-95-N, 37422-100-N, 37422-105-N, 37422-110-N, 37422-115-N, 37422-120-N, 37592-18, 37592-20, 37592-22, 37592-24, 37592-26, 37592-28, 37592-30, 37592-32, 37592-34, 37592-36, 37592-38, 37592-40, 37592-42, 37592-46, 37592-48, 37592-50, 37592-54, 37592-56, 37592-58, 37592-60, 37592-65, 37592-70, 37592-75, 37592-80, 37592-85, 37592-90. 6. Cannulated Screw, Cancellous; Article Numbers: 31851-60, 31851-65, 31851-70, 31851-75, 31851-80, 31851-85, 31851-90, 31851-95, 31851-100, 31851-105, 31851-110, 31851-115, 31851-120, 31851-125, 31851-130, 31851-135, 31851-140, 31851-145, 31851-150, 31851-155, 31851-160, 31851-165, 31851-170, 31851-175, 31851-180, 31851-185, 31851-190, 31851-195, 31851-200, 31854-60, 31854-65, 31854-70, 31854-75, 31854-80, 31854-85, 31854-90, 31854-95, 31854-100, 31854-105, 31854-110, 31854-115, 31854-120, 31854-125, 31854-130, 31854-135, 31854-140, 31854-145, 31854-150, 31854-155, 31854-160, 31854-165, 31854-170, 31854-175, 31854-180, 31854-185, 31854-190, 31854-195, 31854-200. 7. Cortical Screw; Article Numbers: 32351-10, 32351-12, 32351-14, 32351-16, 32351-18, 32351-20, 32351-22, 32351-24, 32351-26, 32351-28, 32351-30, 32351-32, 32351-34, 32351-36, 32351-38, 32351-40, 32351-42, 32351-44, 32351-46, 32351-48, 32351-50, 32351-55, 32351-60, 32351-65, 32351-70, 32351-75, 32351-80, 32351-85, 32352-16, 32352-18, 32352-20, 32352-22, 32352-24, 32352-26, 32352-28, 32352-30, 32352-32, 32352-34, 32352-36, 32352-38, 32352-40, 32352-42, 32352-44, 32352-46, 32352-48, 32352-50, 32352-55, 32352-60, 32352-65, 32352-70, 32352-75, 32352-80, 32352-85, 32352-90, 32352-95, 32352-100, 32352-105, 32352-110, 32352-115, 32352-120, 32455-18, 32455-20, 32455-22, 32455-24, 32455-26, 32455-28, 32455-30, 32455-32, 32455-34, 32455-36, 32455-38, 32455-40, 32455-42, 32455-44, 32455-46, 32455-48, 32455-50, 32455-52, 32455-54, 32455-56, 32455-58, 32455-60, 32455-65, 32455-70, 32455-75, 32455-80, 32455-85, 32455-90, 32475-32. 8. Cortical Screw, Locking; Article Numbers: 37455-18, 37455-20, 37455-22, 37455-24, 37455-26, 37455-28, 37455-30, 37455-32, 37455-34, 37455-36, 37455-38, 37455-40, 37455-42, 37455-44, 37455-46, 37455-48, 37455-50, 37455-52, 37455-54, 37455-56, 37455-60, 37455-65, 37455-70, 37455-75, 37455-80, 37455-85, 37455-90. 9. Curved Plate; Article Numbers: 211911-4, 211911-5, 211911-6, 211911-7, 211911-8, 211911-10, 211911-12, 211911-14, 211911-16, 211911-20. 10. Posterior Column Plate, Left; Article Numbers: 212121-6. 11. Posterior Column Plate, Right; Article Numbers: 212131-6. 12. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-SM. 13. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-LA. 14. Posterior Wall Plate, Extended, Right; Article Numbers: 212111-LA, 212111-SM. 15. Posterior Wall Plate, Left; Article Numbers: 212141-7, 212141-8. 16. Posterior Wall Plate, Right; Article Numbers: 212151-7, 212151-8. 17. PRS Plate; Article Numbers: 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7. 18. Quadrilateral Buttress Plate; Article Numbers: 21208-13, 21209-13. 19. Quadrilateral Buttress Plate; Article Numbers: 21208-11, 21209-11. 20. Rim Plate, Left; Article

Lot/Code Info: 1. Article Number (Lot Numbers): 21218-16 (679/112166, 679/122229, 679/122230, 679/122304), 21219-16 (679/012441, 679/062456, 679/0624561, 679/112167, 679/122228). 2. Article Number (Lot Numbers): 21218-14(679/032417, 679/102231, 679/112158, 679/112164, 679/122231), 21219-14 (679/012505, 679/112159, 679/112165, 679/122227, 679/122305). 3. Article Number (Lot Numbers): 21216-10 (679/032501, 679/062453, 679/072276, 679/072510, 679/092203, 679/092401, 679/112168, 679/112409, 679/122270), 21216-12 (679/032503, 679/062344, 679/062454, 679/072277, 679/092204, 679/112170, 679/112413, 679/122271), 21217-10 (679/032502, 679/062346, 679/072278, 679/092402, 679/092404, 679/102216, 679/112169, 679/112423), 21217-12 (679/022238, 679/062345, 679/072513, 679/092403, 679/112171, 679/122407, 679/122426). 4. Article Number (Lot Numbers): 30591-36 (18/922090), 30591-70 (18/231539, 18/775273), 30591-75 (18/751307), 30591-80 (18/777295), 30591-85 (18/301308), 30591-90 (18/311309). 5. Article Number (Lot Numbers): 37422-12-N (18/145897, 18/461842), 37422-14-N (18/215281, 679/032001, 679/062320, 679/092355, 679/122326), 37422-16-N (679/052229, 679/052307, 679/102214, 679/102306, 679/122329), 37422-18-N (18/240520, 18/452529, 18/473354, 679/052316, 679/102215, 679/102337, 679/122330), 37422-20-N (679/0323147, 679/072306, 679/102211, 679/102338, 679/122331), 37422-22-N (18/092876, 18/543636, 679/012406, 679/062361, 679/072312, 679/102212, 679/102348), 37422-24-N (679/012407, 679/052333, 679/072313, 679/102349), 37422-26-N (679/012435, 679/062316, 679/072322, 679/102353), 37422-28-N (18/192499, 679/012422, 679/032211, 679/062317, 679/062323, 679/072323, 679/102361), 37422-30-N (18/217289, 679/012436, 679/032212, 679/0323142, 679/072324, 679/102354), 37422-32-N (18/218290, 679/012437, 679/052335, 679/052337, 679/072329, 679/112306), 37422-34-N (18/031830, 18/219291, 679/012446, 679/062337, 679/062341, 679/072330, 679/112318), 37422-36-N (18/220292, 18/240540, 18/734742, 679/012447, 679/042317, 679/042321, 679/062003, 679/072334, 679/102361), 37422-38-N (18/105881, 18/221293, 18/362296, 18/412482, 679/012243, 679/022407, 679/052331, 679/052334, 679/072349, 679/112323), 37422-40-N (18/052830, 18/222294, 18/240538, 18/493069, 18/736744, 679/022401, 679/032310, 679/042302, 679/072354, 679/112329), 37422-42-N (18/053831, 18/081544, 18/223295, 18/364298, 18/733745, 679/022402, 679/062371, 679/082304, 679/112330), 37422-44-N (18/054832, 18/224296, 18/365299, 18/737746, 18/781832, 679/022412, 679/042331, 679/042345, 679/082314, 679/112335), 37422-46-N (18/052578, 18/225314, 18/366300, 18/738747, 679/022419, 679/042313, 679/042318, 679/082319, 679/112336), 37422-48-N (18/056834, 18/226315, 679/022423, 679/052324, 679/052328, 679/072316, 679/092314, 679/112337), 37422-50-N (18/227316, 18/740748, 679/022436, 679/042336, 679/052314, 679/092342, 679/112338), 37422-55-N (18/113882, 18/368302, 679/032215, 679/052336, 679/062309, 679/092322, 679/112324), 37422-60-N (18/229318, 18/240517, 18/927095, 28/33034, 679/032403, 679/062349, 679/062351, 679/092325, 679/122307), 37422-65-N (18/118884, 18/230319, 18/271754, 18/743749, 18/761192, 28/35846, 679/032216, 679/072303, 679/092326, 679/122308), 37422-70-N (679/102213, 18/744750, 18/893916, 679/062368, 679/092338, 679/102213, 679/122309), 37422-75-N (18/122888, 18/231839, 679/072304, 679/122306), 37422-80-N (679/122254, 18/124887, 679/062352, 679/122320), 37422-85-N (18/056936, 18/271837, 679/012256, 679/092339), 37422-90-N (18/050600, 18/321273, 679/092340), 37422-95-N (18/130891, 679/092341), 37422-100-N (18/132892, 18/341607, 679/102403), 37422-105-N (679/102404), 37422-110-N (18/136894, 18/371843, 679/092337), 37422-115-N (18/138895, 18/391845, 679/012262), 37422-120-N (18/140896, 679/092349), 37592-18 (679/072351), 37592-20 (18/831792, 18/252862), 37592-22 (18/172773, 679/072356), 37592-24 (679/082301), 37592-26 (18/182774, 679/082303), 37592-28 (679/012140, 679/082310), 37592-30 (18/112775, 679/082317), 37592-32 (679/082312), 37592-34 (18/192863, 679/082313), 37592-36 (679/082318), 37592-38 (679/092308), 37592-40 (679/052116, 679/072314), 37592-42 (679/092310), 37592-46 (18/092772, 679/092312), 37592-48 (679/052118, 679/092313), 37592-50 (679/092343), 37592-54 (679/072315), 37592-56 (18/721587), 37592-58 (679/092334), 37592-60 (679/042213, 679/072325, 679/092345), 37592-65 (679/072331), 37592-70 (679/042289, 679/072340, 679/092353), 37592-75 (18/429442, 679/092351), 37592-80 (679/052204, 679/072341, 679/092335), 37592-85 (679/042291, 679/072342, 679/092354), 37592-90 (679/042292, 679/092352). 6. Article Number (Lot Numbers): 31851-60 (18/373463, 18/813133), 31851-65 (18/374464), 31851-70 (18/375465), 31851-75 (18/376467), 31851-80 (18/125212, 18/377468, 18/431563, 18/867967), 31851-85 (18/044945, 18/378469, 18/441564), 31851-90 (18/045946, 18/343266, 18/451565), 31851-95 (18/046947, 18/128224, 18/379470, 18/461566), 31851-100 (18/129225, 18/471567, 18/821469, 18/860968), 31851-105 (18/380471), 31851-110 (18/901298, 18/387472), 31851-115 (18/381473, 18/048949), 31851-120 (18/049950, 18/133227, 18/511577, 18/862970), 31851-125 (18/050951, 18/347474, 18/521578), 31851-130 (18/051952, 18/344368, 18/531579), 31851-135 (18/382475, 18/541580), 31851-140 (18/052953, 18/551777, 18/863971), 31851-145 (18/054954, 18/137229, 18/345351, 18/561779), 31851-150 (18/138260, 18/191042, 18/346352, 18/571780, 18/797898), 31851-155 (18/201043, 18/384476), 31851-160 (18/062955, 18/799900, 18/866972), 31851-165 (18/063956, 18/211045, 18/385477), 31851-170 (18/141230, 18/221046, 18/348353), 31851-175 (18/064957, 18/142263, 18/386398), 31851-180 (18/065958, 18/143264, 18/388399), 31851-185 (18/389400), 31851-190 (18/066959, 18/390401), 31851-195 (18/067960, 18/391478), 31851-200 (18/013266, 18/392479), 31854-60 (18/393482), 31854-65 (18/394499, 18/691605), 31854-70 (18/070983, 18/395500), 31854-75 (18/071984, 18/396501), 31854-80 (18/072985, 18/397502, 18/731608, 18/871960), 31854-85 (18/149247, 18/240529, 18/741609, 18/872961), 31854-90 (18/150280, 18/398503, 18/751610, 18/873962), 31854-95 (18/399504, 18/761611, 18/874963), 31854-100 (18/400505, 18/771612, 18/868964), 31854-105 (18/401506), 31854-110 (18/073986, 18/869965), 31854-115 (18/074987, 18/402507, 18/801615), 31854-120 (18/403508, 18/870966), 31854-125 (18/404509, 18/821617), 31854-130 (18/075988, 18/405366, 18/831618), 31854-135 (18/076989, 18/406510), 31854-140 (18/407369, 18/851693), 31854-145 (18/408370, 18/861706), 31854-150 (18/160285, 18/409371, 18/871704), 31854-155 (18/410511), 31854-160 (18/1622951, 18/411372, 18/862761, 18/891708), 31854-165 (18/163286, 18/412512), 31854-170 (18/164296, 18/413513), 31854-175 (18/079992, 18/414514), 31854-180 (18/080993, 18/415515), 31854-185 (18/081994, 18/416373, 18/808929), 31854-190 (18/082995), 31854-195 (18/083996, 18/961715), 31854-200 (18/084997, 18/417516). 7. Article Number (Lot Numbers): 32351-10 (18/019937, 18/208200, 18/731287, 679/052205, 679/122249), 32351-12 (18/020938, 18/209211, 18/741316, 679/062203, 679/102243), 32351-14 (18/210212, 18/501230, 18/761312, 679/012324, 679/032524, 679/042419, 679/062225, 679/082501, 679/122207), 32351-16 (18/022940, 18/211212, 18/771313, 679/022311, 679/022533, 679/032525, 679/042421, 679/072201, 679/092501, 679/122204), 32351-18 (18/212213, 18/781322, 18/801041, 679/022312, 679/032526, 679/042427, 679/072202, 679/102501, 679/122208), 32351-20 (18/024942, 18/181975, 18/213214, 18/791323, 679/032527, 679/042428, 679/102502, 679/112225), 32351-22 (18/025943, 18/214215, 18/801324, 18/8013241, 18/821061, 679/052219, 679/112235), 32351-24 (18/026988, 18/215216, 18/811325, 18/8113251, 18/831062, 679/052206, 679/102239), 32351-26 (18/027989, 18/216217, 18/821326, 18/841063, 679/052202, 679/052407, 679/112236), 32351-28 (18/028990, 18/217218, 18/8313271, 679/052220, 679/102235), 32351-30 (18/029991, 18/218219, 18/841314, 679/062205, 679/122260), 32351-32 (18/219220, 18/301035, 18/851315, 18/8513151, 679/012303, 679/052203), 32351-34 (18/220221, 18/311041, 18/861328, 18/961089, 679/052243, 679/112229), 32351-36 (18/230222, 18/411090, 679/052221, 679/112241), 32351-38 (18/131369, 18/1313691, 18/221226, 18/321091, 26/F66144, 679/052207, 679/102247), 32351-40 (18/222223, 18/331092, 679/052208, 679/122243), 32351-42 (18/223224, 18/341093, 18/871329, 18/8713291, 679/112214), 32351-44 (18/351094, 18/881330, 18/8813301, 18/921138, 679/052209, 679/112211), 32351-46 (18/225227, 18/361095, 18/891331, 18/8913311, 18/931313, 679/042217, 679/112215), 32351-48 (18/226228, 18/371096, 679/052210, 679/122244), 32351-50 (18/227229, 18/381097, 18/941314, 679/012304, 679/052211), 32351-55 (18/391098, 18/901332, 18/951142, 18/951315, 679/042218, 679/112237), 32351-60 (18/229231, 18/401099, 18/961316, 679/042283, 679/122250), 32351-65 (18/981144, 679/022326, 679/042284), 32351-70 (18/236233), 32351-75 (18/237234, 679/022328), 32351-80 (18/461103, 679/042286), 32351-85 (18/431104), 32352-16 (679/022406, 679/072207, 679/122427), 32352-18 (679/012501, 679/022344, 679/052182), 32352-20 (18/670753, 679/012453, 679/012504, 679/022345, 679/052184, 679/052311), 32352-22 (18/237340, 679/012454, 679/022346, 679/022506, 679/062101, 679/072208, 679/122003), 32352-24 (18/238437, 18/672755, 679/022404, 679/032379, 679/032528, 679/052312, 679/062102, 679/072209, 679/122424), 32352-26 (18/239357, 18/673756, 679/022352, 679/022405, 679/032512, 679/052313, 679/072210, 679/122416), 32352-28 (18/240358, 18/674757, 679/022411, 679/032267, 679/032324, 679/032529, 679/052303, 679/072211, 679/122418), 32352-30 (18/675758, 18/950241, 679/022417, 679/022513, 679/032325, 679/052304, 679/072213, 679/102414, 679/102513), 32352-32 (18/242360, 18/676759, 679/022418, 679/032323, 679/032530, 679/052305, 679/072214, 679/122421), 32352-34 (18/243361, 18/677760, 679/022426, 679/022514, 679/032326, 679/052301, 679/072280, 679/102401), 32352-36 (18/244362, 18/678761, 679/032327, 679/032531, 679/042274, 679/052302, 679/072282, 679/122422), 32352-38 (18/245363, 18/679762, 679/022428, 679/0323112, 679/032392, 679/032513, 679/072283, 679/112502, 679/122413), 32352-40 (18/246364, 18/680763, 679/012506, 679/022438, 679/032268, 679/032375, 679/042342, 679/072112, 679/072285, 679/112505, 679/122419), 32352-42 (18/247365, 18/681764, 679/012507, 679/012508, 679/032347, 679/042343, 679/062246), 32352-44 (18/248366, 18/682765, 679/012217, 679/012503, 679/032339, 679/062247), 32352-46 (18/249367, 18/683766, 18/819818, 679/012218, 679/022526, 679/032371, 679/042332, 679/062249, 679/072294, 679/102402, 679/122501), 32352-48 (18/250368, 679/022444, 679/022505, 679/032372, 679/062251, 679/102180), 32352-50 (18/251369, 18/685768, 679/012509, 679/022452, 679/032364, 679/042329, 679/062253, 679/072295, 679/112434), 32352-55 (18/252370, 18/686769, 679/022504, 679/032376, 679/062255, 679/072296, 679/072297, 679/122401, 679/122504), 32352-60 (18/253438, 18/687770, 679/012222, 679/022527, 679/032328, 679/062257, 679/072298), 32352-65 (18/254460, 18/688798, 679/022457, 679/022520, 679/032343, 679/062259), 32352-70 (18/255371, 18/823821, 679/032344, 679/032408, 679/042316, 679/062261, 679/082201), 32352-75 (18/256429, 679/022522, 679/032398, 679/032399, 679/032409, 679/062263), 32352-80 (18/257430, 679/022523, 679/0323104, 679/0323107, 679/032410, 679/062265), 32352-85 (679/0323109, 679/0323113, 679/062267), 32352-90 (679/0323138, 679/0323141, 679/062268), 32352-95 (679/0323146, 679/0323148, 679/062271), 32352-100 (679/012230, 679/032266, 679/032411, 679/042301, 679/062273), 32352-105 (679/032412, 679/032509, 679/042311, 679/062275), 32352-110 (679/032413, 679/032521, 679/042312, 679/062277), 32352-115 (679/032418, 679/042319, 679/062279), 32352-120 (679/032419, 679/042320, 679/062281), 32455-18 (18/371232), 32455-20 (18/892124), 32455-22 (18/391234, 18/434375, 679/032395), 32455-24 (18/401235, 18/435376, 26/F62579, 679/032387, 679/032396, 679/092502), 32455-26 (18/411236, 18/436377, 679/032397, 679/092503), 32455-28 (18/437378, 679/032345), 32455-30 (18/256241, 679/032346, 679/032388), 32455-32 (18/438380, 18/441239, 26/F62581, 679/032384), 32455-34 (18/440381, 18/451240, 18/565613, 26/F62918, 679/032385), 32455-36 (18/441382, 18/461241, 26/F62582, 679/032389), 32455-38 (18/442383, 18/471242, 679/022353, 679/032363, 679/092507), 32455-40 (18/481243, 18/4812431, 26/F62583, 26F/62583, 679/022351, 679/032349), 32455-42 (18/491244, 26/F62584), 32455-44 (18/445386, 18/501245, 679/022354, 679/032366), 32455-46 (18/511246, 26/F62585, 679/032317, 679/032367), 32455-48 (18/231444, 18/446387, 679/022355, 679/032368), 32455-50 (18/531248), 32455-52 (18/541249, 679/032318, 679/032369), 32455-54 (18/377660, 18/392952, 18/551250), 32455-56 (679/032373), 32455-58 (18/378662, 18/412953, 18/571252), 32455-60 (679/032319, 679/032374), 32455-65 (18/591254), 32455-70 (18/601255, 26/F62586), 32455-75 (18/611256), 32455-80 (18/621257, 26/F62587), 32455-85 (18/231516, 26/F62588), 32455-90 (18/641259, 679/0323108), 32475-32 (26/F16726). 8. Article Number (Lot Numbers): 37455-18 (18/231558), 37455-20 (18/021319), 37455-22 (18/211320), 37455-24 (18/671425, 18/231558), 37455-26 (18/221322, 18/231449), 37455-28 (18/041323), 37455-30 (18/231324), 37455-32 (18/051325), 37455-34 (18/241326), 37455-36 (18/061375, 26/F62605), 37455-38 (18/251376), 37455-40 (18/532513, 18/691442, 26/F62606), 37455-42 (18/151343, 18/261380), 37455-44 (18/081388), 37455-46 (18/231515), 37455-48 (18/231514), 37455-50 (18/281394), 37455-52 (18/101395), 37455-54 (18/701444), 37455-56 (18/111408, 18/656368), 37455-60 (18/121449, 18/572515), 37455-65 (18/131479), 37455-70 (18/141480, 26/F62607), 37455-75 (18/151481, 26/F62608), 37455-80 (18/686476, 26/F62609), 37455-85 (18/171483, 26/F62610), 37455-90 (18/181484). 9. Article Number (Lot Numbers): 211911-4 (00/0825-10, 679/012425, 679/022531, 679/0323131, 679/062430, 679/0624301, 679/102431, 679/122267), 211911-5 (00/0724-28, 00/1225-04, 679/012426, 679/022321, 679/022518, 679/0323132, 679/052527, 679/0624311, 679/0624312, 679/102432), 211911-6 (00/1024-15, 679/012427, 679/022322, 679/022501, 679/042513, 679/062432, 679/0624322, 679/102433, 679/112177), 211911-7 (00/0724-31, 00/0724-32, 00/0724-33, 00/0724-34, 00/0724-35, 00/0725-16, 00/1225-05, 679/022323, 679/022502, 679/052529, 679/062231, 679/102434), 211911-8 (679/012428, 679/022503, 679/022532, 679/0323135, 679/112178, 679/112407), 211911-10 (00/0724-39, 00/1024-17, 679/0323127, 679/102429, 679/112179, 679/122266), 211911-12 (679/0323128, 679/102228, 679/112203, 679/112219), 211911-14 (679/0323129, 679/102229, 679/112221), 211911-16 (679/0323130, 679/062232, 679/112222), 211911-20 (679/062429, 679/112418, 679/122268). 10. Article Number (Lot Numbers): 212121-6 (679/052152, 679/062338, 679/122235). 11. Article Number (Lot Numbers): 212131-6 (679/062319, 679/122234). 12. Article Number (Lot Numbers): 212101-SM (679/042515, 679/052322, 679/122215, 679/122303, 679/122402). 13. Article Number (Lot Numbers): 212101-LA (00/0724-48, 00/1024-09, 679/062313, 679/062443, 679/112206, 679/122302, 679/122405). 14. Article Number (Lot Numbers): 212111-LA (679/032421, 679/042516, 679/062347, 679/062402, 679/062445, 679/122414), 212111-SM (00/0724-65, 00/1024-10, 00/1024-11, 679/022530, 679/032246, 679/062318, 679/062403, 679/062473, 679/092237, 679/112015, 679/122406). 15. Article Number (Lot Numbers): 212141-7 (00/0724-81, 00/0724-85, 679/032331, 679/052168, 679/062448, 679/122214), 212141-8 (679/022408, 679/032332, 679/052429, 679/062449, 679/0624491, 679/062474, 679/122233). 16. Article Number (Lot Numbers): 212151-7 (00/0624-06, 679/012449, 679/052153, 679/062219, 679/062450, 679/062475, 679/102230, 679/112239), 212151-8 (00/0624-11, 00/0724-51, 679/012450, 679/032248, 679/062451, 679/072508). 17. Article Number (Lot Numbers): 21194-6 (679/042247), 21194-7 (679/042249), 21194-8 (679/042250), 21195-10 (679/042252), 21195-12 (679/042253), 21195-7 (679/032221). 18. Article Number (Lot Numbers): 21208-13 (679/032414, 679/052428, 679/062122, 679/102435, 679/112162, 679/112174, 679/122221, 679/122222), 21209-13 (679/062442, 679/0624421, 679/112163, 679/112175, 679/112408, 679/122236). 19. Article Number (Lot Numbers): 21208-11 (679/012429, 679/062440, 679/0624401, 679/112160, 679/112172, 679/122219), 21209-11 (679/062441, 679/112161, 679/112173, 679/112412, 679/122237, 679/122238, 679/122239). 20. Article Number (Lot Numbers): 212061-10 (00/0724-110, 679/062311, 679/112217, 679/122218), 212061-14 (00/0724-42, 00/0724-47, 679/032238, 679/032337, 679/062312). 21. Article Number (Lot Numbers): 212071-10 (679/032415, 679/052329), 212071-14 (679/032338, 679/032416). 22. Article Number (Lot Numbers): 211751-5 (679/052320, 679/112180, 679/112202, 679/112220), 211771-4 (679/052321, 679/102227, 679/122301). 23. Article Number (Lot Numbers): 211821-10 (679/012423, 679/032333, 679/062426, 679/112176), 211821-11 (00/0724-71, 00/0724-74, 679/032334), 211821-12 (679/022320), 211821-14 (679/012424, 679/122217). 24. Article Number (Lot Numbers): 21161-4 (679/092320, 679/112201), 21161-6 (679/032305, 679/032306, 679/042304, 679/052506, 679/062218), 211621-4 (00/0724-18, 00/0724-63, 679/042305, 679/062423, 679/102226, 679/112414), 211621-6 (00/0825-13, 679/022529, 679/042306, 679/062424, 679/112415). 25. Article Number (Lot Numbers): 211631-6 (00/0125-35, 679/022515, 679/032315, 679/062302, 679/062425, 679/0624251, 679/112411), 211631-8 (00/0724-118, 00/1220-11, 679/062303, 679/122216).

Quantity Affected: 46,637 units

Reason for Recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Type: Voluntary: Firm initiated

Recall Initiated: 2026-01-23

Company