Z-1115-2012

Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC

Name: Z-1115-2012 Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC
Creator: Kerr Corporation
Published: 2010-08-19
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2010-08-19 / Terminated / root cause: manufacturing process

FDA source

Kerr Corporation began a recall of 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... on 2010-08-19. The reason FDA records is "A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as flowable as ideally expected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1115-2012
Status: Terminated
Initiated: 2010-08-19
Posted: 2012-02-28
Terminated: 2012-02-28
Recalling firm: Sybron Dental Specialties, Inc.
Product: 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.
Product code: EBF Material, Tooth Shade, Resin
Reason for recall: A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as flowable as ideally expected.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers: 3487864, 3491581

Product code EBF

K072545Class IIArtiste Se Flowable Composite, Model N280Pentron Clinical Technologies / cleared 2007-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)