Class II FDA device recall · Z-1192-2024

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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.

Why it was recalled

Machining error on cams renders the device unusable.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed 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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

US Nationwide distribution in the state of Utah.

Recall record

Recalling firm: GRAPHENANO DENTAL SL
Product type: Devices
Recall number: Z-1192-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: E-Mail
Origin: Yecla
Recall initiated: 2023-10-24

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1192-2024 · Source: openFDA enforcement.