Z-0213-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2015
- Initiation Date
- October 7, 2015
- Termination Date
- June 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 337 units
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.
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.
Distribution Pattern
Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA.
Code Information
Lot U12511, Kit Lot U19925 (Helioseal F Assortment only), exp. 11.09.2017