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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1192-2024

GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131; g) 95 Multichroma 14LA2, REF GC00157; h) 95 Multichroma 20LB2, REF GC00098; i) 95 Multichroma 20LBL2, REF GC00114; j) 95 Multichroma 16LA3,5, REF GC00132; k) 95 Multichroma 14LA1, REF GC00158; l) 95 Multichroma 24LB1, REF GC00099; m) 95 Multichroma 20LA3,5, REF GC00115; n) 95 Multichroma 16LA3, REF GC00133; o) 95 Multichroma 16LC2, REF GC00091; p) 95 Multichroma 14LBL2, REF GC00134; q) 95 Multichroma 24LBL2, REF GC00092; r) 95 Multichroma 24LA3,5, REF GC00101; s) 95 Multichroma 20LA3, REF GC00117; t) 95 Multichroma 14LB1, REF GC00135; u) 95 Multichroma 24LB2, REF GC00094; v) 95 Multichroma 20LA2, REF GC00119; w) 95 Multichroma14LA3,5, REF GC00137; x) 95 Multichroma 14LC2, REF GC00095; y) 95 Multichroma 24LA3, REF GC00104; z) 95 Multichroma14LA3, REF GC00138 ; used in the manufacture of dentures.

Publicado el 6 de marzo de 2024 · Inicio del retiro: 24 de octubre de 2023

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Machining error on cams renders the device unusable.

Qué hacer

Voluntary: Firm initiated · E-Mail

Detalles del retiro

Fabricante
GRAPHENANO DENTAL SL
Distribuidor
US Nationwide distribution in the state of Utah.
Lote
a) REF GC00089, Lot Number L2309099, UDI/DI 8445644002447, Serial Numbers: S230900857, S230900858, S230900859, S230900860, S230900861, S230900862, S230900863, S230900864, S230900865, S230900866, S230900867, S230900868; b) REF GC00112, Lot Number L2309119, UDI/DI 8445644001549, Serial Numbers: S230901190, S230901197, S230901198, S230901199, S230901200, S230901201, S230901202, S230901203, S230901204, S230901205, S230901206, S230901207, S230901208, S230901209, S230901210; c) REF GC00130, Lot Number L2309124, UDI/DI 8445644000146, Serial Numbers: S230901309, S230901310, S230901311, S230901312, S230901313, S230901314, S230901315, S230901317, S230901318, S230901319, S230901320, S230901321, S230901322, S230901323, S230901324; d) REF GC00090, Lot Number L2309100, UDI/DI 8445644002553, Serial Numbers: S230900889, S230900890, S230900891, S230900892, S230900893, S230900894, S230900900, S230900901, S230900902, S230900903, S230900911; e) REF GC00113, Lot Number L2309120, UDI/DI 8445644001655, Serial Numbers: S230901222, S230901223, S230901224, S230901225, S230901226, S230901227, S230901228, S230901229, S230901230, S230901231, S230901232, S230901233; f) REF GC00131, Lot Number L2309125, UDI/DI 8445644000276, Serial Numbers: S230901329, S230901330, S230901331, S230901333, S230901334, S230901335, S230901341, S230901342, S230901343, S230901344, S230901345, S230901346; g) REF GC00157, Lot Number L2309101, UDI/DI 8445644002867, Serial Numbers: S230900916, S230900917, S230900918, S230900919, S230900920, S230900921, S230900922, S230900923, S230900924, S230900925, S230900939, S230900940, S230900941, S230900942, S230900943; h) REF GC00098, Lot Number L2309115, UDI/DI 8445644000153, Serial Numbers: S230901104, S230901105, S230901106, S230901107, S230901109, S230901110, S230901111, S230901112, S230901113, S230901114, S230901115, S230901116, S230901117, S230901118, S230901121; i) REF GC00114, Lot Number L2309121, UDI/DI 8445644001747, Serial Numbers: S230901238, S230901239, S230901240, S230901241, S230901242, S230901243, S230901244, S230901245, S230901246, S230901247, S230901248, S230901249, S230901250, S230901253, S230901254; j) REF GC00132, Lot Number L2309126, UDI/DI 8445644000344, Serial Numbers: S230901350, S230901352, S230901353, S230901354, S230901355, S230901356, S230901357, S230901358, S230901359, S230901360, S230901361, S230901362, S230901363, S230901364, S230901365; k) REF GC00158, Lot Number L2309102, UDI/DI 8445644002935, Serial Numbers: S230900952, S230900953, S230900954, S230900955, S230900963, S230900964, S230900965, S230900966, S230900967, S230900968, S230900969, S230900970, S230900971, S230900972, S230900973; l) REF GC00099, Lot Number L2309116, UDI/DI 8445644000269, Serial Numbers: S230901134, S230901135, S230901138, S230901139, S230901140, S230901141, S230901142, S230901143, S230901144, S230901145, S230901154, S230901155, S230901156, S230901157, S230901158; m) REF GC00115, Lot Number L2309122, UDI/DI 8445644001853, Serial Numbers: S230901262, S230901263, S230901264, S230901265, S230901266, S230901267, S230901268, S230901269, S230901270, S230901271, S230901272, S230901273, S230901274, S230901275, S230901276; n) REF GC00133, Lot Number L2309127, UDI/DI 8445644000474, Serial Numbers: S230901371, S230901372, S230901373, S230901374, S230901376, S230901377, S230901378, S230901379, S230901380, S230901381, S230901382, S230901383, S230901384, S230901385, S230901386; o) REF GC00091, Lot Number L2309103, UDI/DI 8445644002645, Serial Numbers: S230900985, S230900986, S230900987, S230900988, S230900989, S230900999, S230901000, S230901001, S230901002, S230901003, S230901004; p) REF GC00134, Lot Number L2309128, UDI/DI 8445644000542, Serial Numbers: S230901390, S230901391, S230901392, S230901393, S230901394, S230901395, S230901396, S230901397, S230901399, S230901400, S230901401, S230901402; q) REF GC00092, Lot Number L2309504, UDI/DI 8445644002751, Serial Numbers: S230903007, S230903008, S230903011,
Clasificación de riesgo
Class II
Área (FDA)
device
País
Spain

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