Ultradent Products, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0811-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: February 4, 2013

Date Posted: February 20, 2013

Recall Number: Z-0811-2013

Event ID: 64272

Reason for Recall:

Incorrect packaging of regular set and fast set cartridges.

Status: Terminated

Product Quantity: 32 cartridges

Code Information:

Part No. 5012, Lot No. B7PPC

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated