Z-0811-2013Class III

Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material...

Name: Z-0811-2013 Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material...
Creator: Ultradent Products, Inc.
Published: 2013-02-04
License: https://open.fda.gov/license/

Ultradent Products Inc. / initiated 2013-02-04 / Terminated / root cause: packaging

FDA source

Ultradent Products, Inc. began a recall of Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics on 2013-02-04. FDA classified it as Class III and gives the reason as "Incorrect packaging of regular set and fast set cartridges". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0811-2013
Classification: Class III
Status: Terminated
Initiated: 2013-02-04
Posted: 2013-02-13
Terminated: 2013-05-30
Recalling firm: Ultradent Products Inc.
Product: Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
Product code: ELW Material, Impression
Reason for recall: Incorrect packaging of regular set and fast set cartridges.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated February 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected products. They may continue to use product or dispose unwanted cartridges and reply back to firm indicating acknowledgement of letter and if replacement is needed. Consumers with questions can call the firm at 801-553-4420. For questions regarding this recall call 801-553-4420.
Quantity in commerce: 32 cartridges
Distribution: Nationwide Distribution
Product codes and lots: Part No. 5012, Lot No. B7PPC

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0811-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0811-2013	Class III	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-13
Z-0812-2013	Class III	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-13

Product code ELW

K972027Class IIElite H-D Hydrophilic Vinyl Polysiloxane Impression Materials (Light Body/normal,light Body/fast Setting,regular Body,)Zhermack S.P.A. / cleared 1997-07-16

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)