Z-0583-2016Class II

InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012

Name: Z-0583-2016 InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012
Creator: Ultradent Products, Inc.
Published: 2015-12-22
License: https://open.fda.gov/license/

Ultradent Products Inc. / initiated 2015-12-22 / Terminated / root cause: manufacturing process

FDA source

Ultradent Products, Inc. began a recall of 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... on 2015-12-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0583-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-22
Posted: 2016-01-05
Terminated: 2016-10-19
Recalling firm: Ultradent Products Inc.
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.
Product code: DZN Instruments, Dental Hand
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 157
Distribution: Worldwide Distribution - US Nationwide and the countries of Austria, Canada, Colombia, Denmark, France, Germany, Great Britain, Iceland, and Portugal.
Product codes and lots: lot#s BC2GN and BC4L7

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0583-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0583-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-04

Product code DZN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)