PlainRecalls
FDA Devices Moderate Class II Terminated

ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations

Reported: November 27, 2013 Initiated: September 23, 2013 #Z-0376-2014

Product Description

ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations

Reason for Recall

Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.

Details

Recalling Firm
Ivoclar Vivadent, Inc.
Units Affected
63 refill packs (50 single use applications per refill)
Distribution
US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.
Location
Buffalo, NY

Frequently Asked Questions

What product was recalled?
ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations. Recalled by Ivoclar Vivadent, Inc.. Units affected: 63 refill packs (50 single use applications per refill).
Why was this product recalled?
Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 27, 2013. Severity: Moderate. Recall number: Z-0376-2014.