Home / Recalls / Ultradent Products, Inc. / Z-0812-2013

Z-0812-2013 Class III Terminated

Recalled by Ultradent Products, Inc. — South Jordan, UT

FDA device recall Z-0812-2013 was initiated by Ultradent Products, Inc. on February 4, 2013 and is designated Class III. Reason for recall: Incorrect packaging of regular set and fast set cartridges. The recall status is terminated (terminated May 30, 2013). Affected quantity: 100 cartridges.

Recall Details

Product Type
Devices
Report Date
February 20, 2013
Initiation Date
February 4, 2013
Termination Date
May 30, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100 cartridges

Product Description

Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

Reason for Recall

Incorrect packaging of regular set and fast set cartridges.

Distribution Pattern

Nationwide Distribution

Code Information

Lot No. B7DS3

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FDA data resources