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U.S. Department of Health and Human Services

Class 2 Device Recall GCAM

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  Class 2 Device Recall GCAM see related information
Date Initiated by Firm October 24, 2023
Date Posted February 28, 2024
Recall Status1 Open3, Classified
Recall Number Z-1192-2024
Recall Event ID 93943
510(K)Number K220329  
Product Classification Resin, denture, relining, repairing, rebasing - Product Code EBI
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.
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
Recalling Firm/
Manufacturer		 GRAPHENANO DENTAL SL
Calle De Pau Casals 13 Bajo
Yecla Spain
Manufacturer Reason
for Recall		 Machining error on cams renders the device unusable.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 354 units
Distribution US Nationwide distribution in the state of Utah.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = EBI and Original Applicant = Graphenano Dental S.L.
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