GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 9
FDA device recall Z-1192-2024 · posted 2024-02-28 · Open, Classified
Recall details
- Recalling firm
- GRAPHENANO DENTAL SL
- Reason for recall
- Machining error on cams renders the device unusable.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- EBI
- Quantity affected
- 354 units
- Distribution
- US Nationwide distribution in the state of Utah.
- Date initiated
- 2023-10-24
- Date posted
- 2024-02-28
- Location
- Yecla, Spain
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| G-CAM (K220329) | Graphenano Dental S.L. | 2022-08-16 |