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U.S. Department of Health and Human Services

Class 2 Device Recall InterGuard 5.5mm Econo Refill

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 Class 2 Device Recall InterGuard 5.5mm Econo Refillsee related information
Date Initiated by FirmDecember 22, 2015
Create DateJanuary 05, 2016
Recall Status1 Terminated 3 on October 19, 2016
Recall NumberZ-0583-2016
Recall Event ID 72814
Product Classification Instruments, dental hand - Product Code DZN
ProductInterGuard 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.
Code Information lot#s BC2GN and BC4L7
Recalling Firm/
Manufacturer		 Ultradent Products, Inc.
505 W 10200 S
South Jordan UT 84095-3935
For Additional Information ContactKaren Kakunes
801-553-4366
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionUltradent 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 in Commerce157
DistributionWorldwide Distribution - US Nationwide and the countries of Austria, Canada, Colombia, Denmark, France, Germany, Great Britain, Iceland, and Portugal.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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