Recall Z-0583-2016 ยท DZN Instruments, Dental Hand
Ultradent Products, Inc.
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.
| Date | Dec 22, 2015 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Ultradent Products sent an Urgent Medical Device Correction letter dated December 21, 2015 to affected customers via FedEx. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discard remaining inventory. Replacement product will be sent to each of the identified customers upon completion. For questions regarding the recall call 801-553-4366 or 801-553-4220. |
| Quantity | 157 |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Austria, Canada, Colombia, Denmark, France, Germany, Great Britain, Iceland, and Portugal. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.