FDAOctober 24, 2023device

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 ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Machining error on cams renders the device unusable.

What to do

FDA enforcement status: Ongoing

Brands named

graphenano dental slgraphenanographenano dental

UPCs

844564400244784456440015498445644000146844564400255384456440016558445644000276844564400286784456440001538445644001747844564400034484456440029358445644000269

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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