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,

Hazard

Machining error on cams renders the device unusable.

Details from the source

Reason for recall: Machining error on cams renders the device unusable. Distribution: US Nationwide distribution in the state of Utah. Quantity: 354 units Lot/code info: 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, S230901198, S230901199, S230901200, S230901201, S230901202, S230901203, S230901204, S230901205, S230901206, S230901207, S230901208, S230901209, S230901210; c) REF GC00130, Lot Number L2309124, UDI/DI 8445644000146, Serial Numbers: S230901309, S230901310, S230901311, S230901312, S230901313, S230901314, S230901315, S230901317, S230901318, S230901319, S230901320, S230901321, S230901322, S230901323, S230901324; d) REF GC00090, Lot Number L2309100, UDI/DI 8445644002553, Serial Numbers: S230900889, S230900890, S230900891, S230900892, S230900893, S230900894, S230900900, S230900901, S230900902, S230900903, S230900911; e) REF GC00113, Lot Number L2309120, UDI/DI 8445644001655, Serial Numbers: S230901222, S230901223, S230901224, S230901225, S230901226, S230901227, S230901228, S230901229, S230901230, S230901231, S230901232, S230901233; f) REF GC00131, Lot Number L2309125, UDI/DI 8445644000276, Serial Numbers: S230901329, S230901330, S230901331, S230901333, S230901334, S230901335, S230901341, S230901342, S230901343, S230901344, S230901345, S230901346; g) REF GC00157, Lot Number L2309101, UDI/DI 8445644002867, Serial Numbers: S230900916, S230900917, S230900918, S230900919, S23

UPC codes

8445644002447, 8445644001549, 8445644000146, 8445644002553, 8445644001655, 8445644000276, 8445644002867, 8445644000153, 8445644001747, 8445644000344, 8445644002935, 8445644000269, 8445644001853, 8445644000474, 8445644002645, 8445644000542, 8445644002751, 8445644000467, 8445644002058, 8445644000672, 8445644002959, 8445644002256, 8445644000870, 8445644003048, 8445644000757, 8445644000948

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.