Ivoclar A. G.: Medical Device Recall in 2015 - (Recall #: Z-0213-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.

Product Classification:

Class II

Date Initiated: October 7, 2015

Date Posted: November 11, 2015

Recall Number: Z-0213-2016

Event ID: 72290

Reason for Recall:

A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.

Status: Terminated

Product Quantity: Domestic: 337 units

Code Information:

Lot U12511, Kit Lot U19925 (Helioseal F Assortment only), exp. 11.09.2017

Distribution Pattern:

Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA.

Voluntary or Mandated:

Voluntary: Firm initiated