Dental Prosthetic Material Recall for Machining Defects
GRAPHENANO Dental G-CAM denture manufacturing material is being recalled due to machining errors that render the product unusable. The recall affects 354 units distributed in Utah.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device recall with a manufacturing defect that renders the product unusable. No illnesses or injuries have been reported, and the hazard is functional rather than a direct health threat.
Plain-English summary
GRAPHENANO Dental G-CAM is a material used in the manufacture of dentures, available in multiple formulations identified by product code, reference number, and lot information.
A machining error affecting the internal cams of the product has been identified. This error renders the product unsuitable for denture manufacturing.
The recall affects 354 units that were distributed in Utah. The affected products are identified by specific lot numbers, reference numbers, and serial numbers.
Dental professionals and patients who have received this product should verify whether their material is from the affected lots by checking the serial numbers. Any recalled units should not be used.
The recalled product
- 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…
- Manufacturer
- GRAPHENANO DENTAL SL
- Affected units
- 354
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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