FDA Enforcement
Class II
Terminated
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.
Recall: Z-0583-2016
·
Reported January 13, 2016
Enforcement
- Recall Number
- Z-0583-2016
- Event ID
- 72814
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ultradent Products, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 13, 2016
- Initiation Date
- December 22, 2015
- Classification Date
- January 4, 2016
- Termination Date
- October 19, 2016
- Address
- 505 W 10200 S, N/A, South Jordan, UT, 84095-3935, United States
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
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.
Code Info
lot#s BC2GN and BC4L7
Distribution
Worldwide Distribution - US Nationwide and the countries of Austria, Canada, Colombia, Denmark, France, Germany, Great Britain, Iceland, and Portugal.
Quantity
157