Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intend

FDA device recall Z-0455-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Kerr Corporation

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.

Action taken

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

Status

Terminated

Product code

EMA

Quantity affected

100 Units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of: Armenia, Russia and Ukraine.

Date initiated

2011-03-03

Date posted

2012-01-11

Date terminated

2012-01-09

Location

Orange, CA