Class II — GRAPHENANO DENTAL SL
| Recalling firm | Graphenano Dental, SL |
|---|---|
| Registered facility | GRAPHENANO DENTAL, SL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Machining error on cams renders the device unusable. |
| 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 GC001… |
| Quantity | 354 units |
| Distribution | US Nationwide distribution in the state of Utah. |
| Initiated | 2023-10-24 |
| Classified | 2024-02-28 |
| Recall number | Z-1192-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GRAPHENANO DENTAL SL (Z-1192-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93943/
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