Device product
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
Z-1883-2018
Product summary
- Event
- Event 79994
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11
- Official record key
device-enforcement:Z-1883-2018
Official wording
Reason: The products are labeled with an incorrect product number.
Code information: Batch I37640
Distribution pattern: The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
Derived failure modes
-
Unknown
The products are labeled with an incorrect product number.