Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental s
FDA device recall Z-0213-2016 · posted 2015-11-04 · Terminated
Recall details
- Recalling firm
- Ivoclar A. G.
- 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.
- Action taken
- Ivoclar Vivadent sent an Urgent Medical Device Recall Letter dated October 7, 2015, with Response Forms via Certified Mail, Return Receipt Requested. Dealers were also contacted via telephone/e-mail and informed to expect the letter. Dealers are requested to check their stock and return any affected material for credit, plus notify their customers of the recall. For questions, please contact Ivoclar Vivadent Customer Service at 1-800-533-6825.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- EBC
- Quantity affected
- Domestic: 337 units
- Distribution
- Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA.
- Date initiated
- 2015-10-07
- Date posted
- 2015-11-04
- Date terminated
- 2016-06-14
- Location
- Schaan, Liechtenstein
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HELIOSEAL F (K932078) | Ivoclar North America, Inc. | 1993-09-15 |