Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Product Usage: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates.
FDA Recall Z-0455-2012 · Posted 2012-01-11
Recalling FirmKerr Corporation
Recall StatusTerminated
Product CodeEMA
Date Initiated2011-03-03
Date Terminated2012-01-09
Product Quantity100 Units
Reason for Recall
The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product.
Firm Action
Pentron Clinical sent an URGENT: Medical Device Recall letter dated April 20, 2011 to all affected customers. The letter described the product, problem and actions to be taken. Customers were instructed to examine their inventory and quarantine all product(s) subject to recall for return and exchange at no charge. In addition, the letter states that if the product was further distributed to contact their customers and notify them of the recall. Customers were also asked to complete and return the enclosed Recall Return Form.
Contact Pentron Clinical Customer Service at (800) 551-0283, (option 1) directly to handle the arrangement of a quick return and replacement.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of: Armenia, Russia and Ukraine.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.