Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Artiste Maverick Tint

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Artiste Maverick Tintsee related information
Date Initiated by FirmMarch 03, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on January 09, 2012
Recall NumberZ-0455-2012
Recall Event ID 60551
Product Classification Cement, dental - Product Code EMA
ProductArtiste 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.
Code Information Part Number: N36TB, Lot/Serial Number: 3416180
FEI Number 2024312
Recalling Firm/
Manufacturer		 Kerr Corporation
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7400
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionPentron 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.
Quantity in Commerce100 Units
DistributionWorldwide Distribution - USA (nationwide) and the countries of: Armenia, Russia and Ukraine.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-