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Terminated

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

FDA Recall Z-0376-2014 · Posted 2013-11-21

Recalling FirmIvoclar Vivadent, Inc.
Recall StatusTerminated
Product CodeMZW
Date Initiated2013-09-23
Date Terminated2016-05-27
Product Quantity63 refill packs (50 single use applications per refill)

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.

Firm Action

The firm, Ivoclar Vivadent, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 19, 2013 via first class mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to check your stock and segregate any material marked batch R59595; contact the Ivoclar Vivadent Customer Service at 800-533-6825 as soon as possible between the hours of 9:00am and 7:00pm EST Monday through Friday and a representative will arrange to have your stock replaced; both unopened and opened packages can be returned; and complete and return the Medical Device Recall Return Response Acknowledgment and Receipt Form. Please communicate locally with Ivoclar Vivadent Customer Service at 800-533-6825 for any questions.

Root Cause

Material/Component Contamination

Distribution Pattern

US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093744EXCITE F AND EXCITE DSCIvoclar Vivadent, Inc. · 2010-03-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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