Z-0665-2018Class III

Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

Name: Z-0665-2018 Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Creator: Ivoclar Vivadent, Inc.
Published: 2017-08-03
License: https://open.fda.gov/license/

Ivoclar Vivadent, Inc. / initiated 2017-08-03 / Terminated / root cause: manufacturing process

FDA source

Ivoclar Vivadent, Inc. began a recall of Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 on 2017-08-03. FDA classified it as Class III and gives the reason as "Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring". 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-0665-2018
Classification: Class III
Status: Terminated
Initiated: 2017-08-03
Posted: 2018-02-21
Terminated: 2018-08-28
Recalling firm: Ivoclar Vivadent, Inc.
Product: Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Product code: EBF Material, Tooth Shade, Resin
Reason for recall: Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm sent letters to consignees on August 3, 2017 instructing them to segregate the recalled product and arrange for a replacement of stock.
Quantity in commerce: 2,153 units
Distribution: US and Canada
Product codes and lots: Batch: V35109 Exp. date: 01.10.2020; Batch: V40817 Exp. date: 13.11.2020; Batch: V48597 Exp. date: 30.12.2020; Batch: V48938 Exp. date: 31.12.2020 Batch: W12251 Exp. date: 31.03.2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0665-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0665-2018	Class III	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21
Z-0666-2018	Class III	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21
Z-0667-2018	Class III	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21
Z-0668-2018	Class III	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21

Product code EBF

K884588Class IIHeliomolar(r) Dental RestorativeWilliams Dental Co., Inc. / cleared 1989-01-27

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)