GRAPHENANO DENTAL G-CAM — Class II medical device recall Z-1192-2024
Ongoing recall by GRAPHENANO DENTAL SL, reported 2024-03-06, distributed nationwide. Machining error on cams renders the device unusable.
| Recall number | Z-1192-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GRAPHENANO DENTAL SL, Yecla, Spain |
| Recall initiated | 2023-10-24 |
| Classified | 2024-02-28 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 354 units |
| UPC / GTIN / UDI-DI | 08445644000146, 08445644000153, 08445644000269, 08445644000276, 08445644000344, 08445644000467, 08445644000474, 08445644000542, 08445644000672, 08445644000757, 08445644000870, 08445644000948, 08445644001549, 08445644001655, 08445644001747, 08445644001853, 08445644002058, 08445644002256, 08445644002447, 08445644002553, 08445644002645, 08445644002751, 08445644002867, 08445644002935, 08445644002959 and 1 more |
| Lot numbers | L2309099, L2309100, L2309101, L2309102, L2309103, L2309105, L2309106, L2309115, L2309116, L2309117, L2309119, L2309120, L2309121, L2309122, L2309123, L2309124, L2309125, L2309126, L2309127, L2309128, L2309130, L2309131, L2309132, L2309133, L2309177, L2309504 |
| Serial numbers | S230900857, S230900858, S230900859, S230900860, S230900861, S230900862, S230900863, S230900864, S230900865, S230900866, S230900867, S230900868, S230900889, S230900890, S230900891, S230900892, S230900893, S230900894, S230900900, S230900901, S230900902, S230900903, S230900911, S230900916, S230900917 and 329 more |
| Model numbers | GC00089, GC00090, GC00091, GC00092, GC00094, GC00095, GC00098, GC00099, GC00101, GC00104, GC00112, GC00113, GC00114, GC00115, GC00117, GC00119, GC00130, GC00131, GC00132, GC00133, GC00134, GC00135, GC00137, GC00138, GC00157 and 1 more |
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 for recall
Machining error on cams renders the device unusable.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1192-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.