Device product
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.
Z-0583-2016
Product summary
- Event
- Event 72814
- Status
- Terminated
- Classification
- Class II
- Quantity
- 157
- Official record key
device-enforcement:Z-0583-2016
Official wording
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 information: lot#s BC2GN and BC4L7
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Austria, Canada, Colombia, Denmark, France, Germany, Great Britain, Iceland, and Portugal.
Derived failure modes
-
Unknown
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.