Brand Name: I.T.S. Pelvic Reconstruction System recall (I.T.S. GmbH)

Medical deviceClass IIOngoing

Summary: I.T.S. GmbH is recalling 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. Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

What is being recalled

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

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W. (states named: Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, West Virginia)

How to tell if yours is affected

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).

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from I.T.S. GmbH · all medical device recalls · recalls from January 2026

Official FDA record