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GRAPHENANO DENTAL G-CAM, Product Codes recallZ-1192-2024 · Graphenano Dental Sl · initiated Oct 24, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Graphenano Dental Sl or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Machining error on cams renders the device unusable.

FDA root cause category: Process control

What the company is doing

Graphenano Dental notified its sole consignee on 10/24/2023 via email. The notice explained the problem with the device and requested that the consignee quarantine all affected devices pending further instructions. A Graphenano employee examined all quarantined product at the consignee for defective devices and were subsequently destroyed.

Recall details

Recall number
Z-1192-2024
Status
Open, Classified
Initiated by the company
Oct 24, 2023
Posted by the FDA
Feb 28, 2024
Recalling firm
Graphenano Dental Sl
Quantity
354 units
Product code
EBI
FDA submissions
K220329
Distribution
US Nationwide distribution in the state of Utah.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (6k characters)

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

Devices named in this recall

26 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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