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Recall Observatory FDA recall evidence

Device product

DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F

Z-2436-2019

July 19, 2019

Class II

Product summary

Firm
Coltene /Whaledent AG
Event
Event 83396
Status
Terminated
Classification
Class II
Quantity
20 units of 5 burs/unit
Official record key
device-enforcement:Z-2436-2019

Official wording

Reason: A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length.

Code information: Lot/Batch Number J22952

Distribution pattern: GA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length.