Device recall

Z-3214-2017: Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container…

FDA device recall · Class II · Ultradent Products, Inc.

Key facts

Recall number (Z-number) Z-3214-2017
Recall event 77891
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.
Product code EKN
Recalling firm Ultradent Products, Inc.
Recall class Class II
Status Terminated
Termination date Jan 4, 2018
FEI number 1718912

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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