Recall Z-1192-2024 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
GRAPHENANO DENTAL SL
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 Mu
| Date | Feb 28, 2024 (initiated Oct 24, 2023) |
| Status | Open, Classified |
| Reason | Machining error on cams renders the device unusable. |
| Root cause | 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 | 354 units |
| Distribution | US Nationwide distribution in the state of Utah. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220329 | G-CAM Graphenano Dental S.L., Aug 16, 2022 |