Z-3218-2017Class II

Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile

Name: Z-3218-2017 Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile
Creator: Ultradent Products, Inc.
Published: 2017-08-04
License: https://open.fda.gov/license/

Ultradent Products Inc. / initiated 2017-08-04 / Terminated / root cause: labeling and UDI

FDA source

Ultradent Products, Inc. began a recall of Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed... on 2017-08-04. FDA classified it as Class II and gives the reason as "The barcode label was placed underneath the sterile barrier and the product was re-wrapped". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3218-2017
Classification: Class II
Status: Terminated
Initiated: 2017-08-04
Posted: 2017-09-26
Terminated: 2018-01-04
Recalling firm: Ultradent Products Inc.
Product: Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 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 Point, Paper, Endodontic
Reason for recall: The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: The recalling firm issued letters dated August 4, 2017 via certified mail,2-day delivery mail, or email on August 4, 2017. The letter identified the affected product, problem, and actions to be taken. For questions contact Regulatory Affairs Specialist at Ultradent Products, Inc.
Quantity in commerce: 62 units
Distribution: Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
Product codes and lots: Lot numbers BCKKP, BD2D4, BD8BY, BDH3Q, and BDTBL

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3218-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3214-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-26
Z-3215-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-26
Z-3216-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-26
Z-3217-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-26
Z-3218-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-26

Product code EKN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)