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GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichrom...

FDA Device Recall #Z-1192-2024 — Class II — October 24, 2023

Recall Summary

Recall Number Z-1192-2024
Classification Class II — Moderate risk
Date Initiated October 24, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GRAPHENANO DENTAL SL
Location Yecla
Product Type Devices
Quantity 354 units

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.

Reason for Recall

Machining error on cams renders the device unusable.

Distribution Pattern

US Nationwide distribution in the state of Utah.

Lot / Code Information

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

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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