Home / Recalls / Ultradent Products, Inc. / Z-0583-2016

Z-0583-2016 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
January 13, 2016
Initiation Date
December 22, 2015
Termination Date
October 19, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
157

Product Description

InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion.

Reason for Recall

Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed.

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of Austria, Canada, Colombia, Denmark, France, Germany, Great Britain, Iceland, and Portugal.

Code Information

lot#s BC2GN and BC4L7

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