Recall Z-1115-2012 ยท EBF Material, Tooth Shade, Resin
Kerr Corporation
Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC. Product Usage: The intended use of this device is as a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include self-etch base liner, restorations of carious lesions, Class I, III and V cavity preparations and pitt and fissure sealant.
| Date | Feb 28, 2012 (initiated Aug 19, 2010) |
| Status | Terminated |
| Reason | A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as flowable as ideally expected. |
| Root cause | Nonconforming Material/Component |
| Action | Pentron Clinical sent a Medical Device Recall letter dated September 8, 2010 (via USPS 1st class mail) to all affected customers. The letter identified the affected product, the reason for the recall and the actions to be taken. Customers were instructed to examine their inventory for the affected product, return any remaining in stock and complete and fax back the enclosed recall return form. Customers were advised to contact Pentron Clinical Customer Service at (800) 551-0283, (option 1) directly to handle the arrangements of a quick return and replacement. |
| Quantity | 382 units total (207 units in US) |
| Distribution | Worldwide Distribution - USA (nationwide) in the countries of Austria, Bulgaria, France, Great Britain, Netherlands, Japan, Lebanon, Malaysia and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072545 | ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 Pentron Clinical Technologies, Oct 26, 2007 |