Z-0583-2016 Class II Terminated
FDA device recall Z-0583-2016 was initiated by Ultradent Products, Inc. on December 22, 2015 and is designated Class II. 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 distribute… The recall status is terminated (terminated October 19, 2016). Affected quantity: 157.
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