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

FDA device recall Z-1026-2016 · posted 2016-02-29 · Terminated

Recall details

Recalling firm

Ivoclar Vivadent, Inc.

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.

Action taken

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 recall.us@ivoclarvivadent.com. 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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

EBC

Quantity affected

Domestic: 406 units

Distribution

Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.

Date initiated

2016-02-12

Date posted

2016-02-29

Date terminated

2017-05-08

Location

Buffalo, NY

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