Recall archive / FDA device enforcement

GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c... — FDA record Z-1192-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 24, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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.
Reason: Machining error on cams renders the device unusable.
Classification: Class II
Recalling firm: GRAPHENANO DENTAL SL
Quantity: 354 units
Agency-reported status: Ongoing
Source record identifier: Z-1192-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, S230903012, S230903013, S230903014, S230903015, S230903016, S230903017, S230903018, S230903019, S230903023, S230903024, S230903025, S230903026; r) REF GC00101, Lot Number L2309117, UDI/DI 8445644000467, Serial Numbers: S230901168, S230901169, S230901170, S230901171, S230901172, S230901173, S230901174, S230901179, S230901180, S230901181, S230901182, S230901183, S230901184, S230901185, S230901186; s) REF GC00117, Lot Number L2309177, UDI/DI 8445644002058, Serial Numbers: S230901558, S230901559, S230901560, S230901561, S230901562, S230901563, S230901564, S230901565, S230901566; t) REF GC00135, Lot Number L2309130, UDI/DI 8445644000672, Serial Numbers: S230901411, S230901412, S230901413, S230901414, S230901415, S230901416, S230901417, S230901418, S230901421, S230901422, S230901423, S230901424, S230901425, S230901426, S230901427; u) REF GC00094, Lot Number L2309105, UDI/DI 8445644002959, Serial Numbers: S230901046, S230901047, S230901048, S230901052, S230901053, S230901054, S230901055, S230901056, S230901057, S230901058, S230901064; v) REF GC00119, Lot Number L2309123, UDI/DI 8445644002256, Serial Numbers: S230901286, S230901287, S230901288, S230901289, S230901290, S230901291, S230901292, S230901293, S230901294, S230901295, S230901296, S230901297, S230901298; w) REF GC00137, Lot Number L2309131, UDI/DI 8445644000870, Serial Numbers: S230901432, S230901435, S230901436, S230901437, S230901438, S230901439, S230901440, S230901441, S230901442, S230901443, S230901444; x) REF GC00095, Lot Number L2309106, UDI/DI 8445644003048, Serial Numbers: S230901067, S230901068, S230901069, S230901070, S230901071, S230901072, S230901073, S230901074, S230901086, S230901087, S230901088, S230901089, S230901090, S230901091, S230901092; y) REF GC00104, Lot Number L2309132, UDI/DI 8445644000757, Serial Numbers: S230901460, S230901461, S230901462, S230901463, S230901464, S230901465, S230901466, S230901468, S230901469, S230901470, S230901471, S230901472, S230901473, S230901474, S230901475; z) REF GC00138 , Lot Number L2309133, UDI/DI 8445644000948, Serial Numbers: S230901478, S230901479, S230901480, S230901481, S230901483, S230901484, S230901485, S230901486, S230901487, S230901488, S230901489, S230901491, S230901492, S230901493, S230901494

Label field

Details supplied by the agency

Lot, code or applicability

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, S230903012, S230903013, S230903014, S230903015, S230903016, S230903017, S230903018, S230903019, S230903023, S230903024, S230903025, S230903026; r) REF GC00101, Lot Number L2309117, UDI/DI 8445644000467, Serial Numbers: S230901168, S230901169, S230901170, S230901171, S230901172, S230901173, S230901174, S230901179, S230901180, S230901181, S230901182, S230901183, S230901184, S230901185, S230901186; s) REF GC00117, Lot Number L2309177, UDI/DI 8445644002058, Serial Numbers: S230901558, S230901559, S230901560, S230901561, S230901562, S230901563, S230901564, S230901565, S230901566; t) REF GC00135, Lot Number L2309130, UDI/DI 8445644000672, Serial Numbers: S230901411, S230901412, S230901413, S230901414, S230901415, S230901416, S230901417, S230901418, S230901421, S230901422, S230901423, S230901424, S230901425, S230901426, S230901427; u) REF GC00094, Lot Number L2309105, UDI/DI 8445644002959, Serial Numbers: S230901046, S230901047, S230901048, S230901052, S230901053, S230901054, S230901055, S230901056, S230901057, S230901058, S230901064; v) REF GC00119, Lot Number L2309123, UDI/DI 8445644002256, Serial Numbers: S230901286, S230901287, S230901288, S230901289, S230901290, S230901291, S230901292, S230901293, S230901294, S230901295, S230901296, S230901297, S230901298; w) REF GC00137, Lot Number L2309131, UDI/DI 8445644000870, Serial Numbers: S230901432, S230901435, S230901436, S230901437, S230901438, S230901439, S230901440, S230901441, S230901442, S230901443, S230901444; x) REF GC00095, Lot Number L2309106, UDI/DI 8445644003048, Serial Numbers: S230901067, S230901068, S230901069, S230901070, S230901071, S230901072, S230901073, S230901074, S230901086, S230901087, S230901088, S230901089, S230901090, S230901091, S230901092; y) REF GC00104, Lot Number L2309132, UDI/DI 8445644000757, Serial Numbers: S230901460, S230901461, S230901462, S230901463, S230901464, S230901465, S230901466, S230901468, S230901469, S230901470, S230901471, S230901472, S230901473, S230901474, S230901475; z) REF GC00138 , Lot Number L2309133, UDI/DI 8445644000948, Serial Numbers: S230901478, S230901479, S230901480, S230901481, S230901483, S230901484, S230901485, S230901486, S230901487, S230901488, S230901489, S230901491, S230901492, S230901493, S230901494

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide distribution in the state of Utah.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Mar 6, 2024
Recall initiation date: Oct 24, 2023
Center classification date: Feb 28, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records