Date Initiated by Firm |
October 22, 2010 |
Date Posted |
February 13, 2012 |
Recall Status1 |
Terminated 3 on February 13, 2012 |
Recall Number |
Z-1006-2012 |
Recall Event ID |
59936 |
510(K)Number |
K052106
|
Product Classification |
Material, tooth shade, resin - Product Code EBF
|
Product |
Flow Tec Part Number 3784-514, Syringe Lot Number 165741
The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc. |
Code Information |
Syringe Lot Number: 165741 Package Lot Numbers: 167025, 167312, and 168495 |
Recalling Firm/ Manufacturer |
Sybron Dental Specialties 1717 W Collins Ave Orange CA 92867-5422
|
For Additional Information Contact |
714-516-7480
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
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. |
Quantity in Commerce |
772 units in total |
Distribution |
Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and Kuwait |
Total Product Life Cycle |
TPLC Device Report
|
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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.
|
510(K) Database |
510(K)s with Product Code = EBF and Original Applicant = PENTRON CLINICAL TECHNOLOGIES
|