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Recall Observatory FDA recall evidence

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

April 13, 2018

Class II

Product summary

Firm
Coltene Whaledent Inc
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

    reason.no_named_rule · v1.0.0

    The products are labeled with an incorrect product number.