Artiste Flowable Value Pack Part Number N28VA, Syringe Lot Number 165741 The intended use of the device is as a light cu

FDA device recall Z-1000-2012 · posted 2012-02-13 · Terminated

Recall details

Recalling firm

Sybron Dental Specialties

Reason for recall

The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude.

Action taken

Sybron Dental sent a Recall Letter dated November 15, 2010 to consignees informing them of the above mentioned public reason for recall and asking them to determine if they have any affected products in their inventory and requesting their cooperation in returning any affected product which they still have in their stock. Product was to be returned and replaced at no charge. They also requested that consignees complete and fax back an enclosed return from , whether or not they had any product to return. Consignees were told to call Pentron Customer Service at (800) 551-0283 directly to handle the arrangements of a quick return and replacement. Authorized Petron Clinical distributors were asked to identify and recover the affected product lots that may have been shipped to their customers.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

EBF

Quantity affected

771 units in total

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and Kuwait

Date initiated

2010-10-22

Date posted

2012-02-13

Date terminated

2012-02-13

Location

Orange, CA

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