Z-1026-2016Class II

Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25...

Name: Z-1026-2016 Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25...
Creator: Ivoclar Vivadent, Inc.
Published: 2016-02-12
License: https://open.fda.gov/license/

Ivoclar Vivadent, Inc. / initiated 2016-02-12 / Terminated / root cause: manufacturing process

FDA source

Ivoclar Vivadent, Inc. began a recall of Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ----... on 2016-02-12. FDA classified it as Class II and gives the reason as "Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear...". 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-1026-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-12
Posted: 2016-02-29
Terminated: 2017-05-08
Recalling firm: Ivoclar Vivadent, Inc.
Product: Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
Product code: EBC Sealant, Pit And Fissure, And Conditioner
Reason for recall: Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
Action: Ivoclar Vivadent sent an Urgent Medical Device Recall letter dated February 11, 2016, to all consignees via Certified Mail, Return Receipt Requested. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to complete, sign and return the attached acknowledgement form and return it to Ivoclar Vivadent via fax (716) 691-2294 or e-mail at [email protected]. Contact Ivoclar Vivadent Customer Service at 1-800-533-6825 as soon as possible between the hours of 8:00 am and 6:00 pm EST Monday through Friday and a representative will arrange to pick up your affected materials for return and credit. Please notify your customers of this issue and return the product to us. For questions, please contact Ivoclar Vivadent Customer Service at 800-533-6825.
Quantity in commerce: Domestic: 406 units
Distribution: Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.
Product codes and lots: REF/Product Code/Art. No. 558521AN, Lot U29336 (exp. 10/5/2020); REF/Product Code/Art. No. 558520AN, Lots U33966, U35661, U50469 (exp. 10/5/2020)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1026-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1026-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-02-29

Product code EBC

K813015Class IIHeliosealVivadent (Usa), Inc. / cleared 1981-12-02

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)