FDA Device recall Z-1192-2024
GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089
- FDA Device
- Class II
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class II recall of GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089 by Graphenano Dental Sl, citing machining error on cams renders the device unusable.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1192-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-24 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Graphenano Dental Sl |
| Distribution | US |
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
Machining error on cams renders the device unusable.
Identifiers
| code_info | a) REF GC00089, Lot Number L2309099, UDI/DI 8445644002447, Serial Numbers: S230900857, S230900858, S230900859, S230900…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 84456440 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1192-2024%22
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