Recall Z-0811-2013
Ultradent Products, Inc. · initiated February 4, 2013
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Part No. 5012, Lot No. B7PPC
Reason for recall
Incorrect packaging of regular set and fast set cartridges.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-0811-2013
- Initiated
- February 4, 2013
- Posted by FDA
- February 13, 2013
- Terminated
- May 30, 2013
- Product code
- ELW – Material, Impression
- Quantity
- 32 cartridges
- Distribution
- Nationwide Distribution
- Recalling firm
- Ultradent Products, Inc., South Jordan, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0812-2013 Class III | Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml…Incorrect packaging of regular set and fast set cartridges. | 02/04/2013Terminated |