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Recall Observatory FDA recall evidence

Device product

Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.

Z-3214-2017

August 04, 2017

Class II

Product summary

Firm
Ultradent Products, Inc.
Event
Event 77891
Status
Terminated
Classification
Class II
Quantity
61 units
Official record key
device-enforcement:Z-3214-2017

Official wording

Reason: The barcode label was placed underneath the sterile barrier and the product was re-wrapped.

Code information: Lot numbers BCDZQ, BCPRC, and BD3MT

Distribution pattern: Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The barcode label was placed underneath the sterile barrier and the product was re-wrapped.