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.
Recall
- Recall Number
- Z-1115-2012
- Event Number
- 61239
- Firm
- Kerr Corporation
- FEI Number
- 2024312
- Product Code
- EBF
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 19, 2010
- Posted
- February 28, 2012
- Terminated
- February 28, 2012
- Address
- 1717 W Collins Ave, Orange, CA, 92867-5422
Description
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.
A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as flowable as ideally expected.
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.
Worldwide Distribution - USA (nationwide) in the countries of Austria, Bulgaria, France, Great Britain, Netherlands, Japan, Lebanon, Malaysia and South Africa.
382 units total (207 units in US)