Tuesday, April 28, 2015

Important Product Correction: iTero Disposable Scanner Sleeves

iTero Logo.png
 
I have been an iTero user for about 6 years now and I have had a great experience both with the company and the services they provide.  Today is another reason why I’m impressed with them.
 
I received this on Monday & thought I’d pass it along to other iTero users:
 
Dear Customrer:
 
We are writing to inform you that Cadent Ltd a division of Align Technology, Inc. is initiating a voluntary product correction of the iTero disposable Scanner Sleeves used with the iTero HDU intraoral scanner wand and is replacing then as needed.  This notice affects approximately 5,000 iTero disposable Scanner Sleeves with part number (P/N) MA15145-A and manufacturing lot number (MLot )03414.  The iTero disposable Scanner Sleeves were distributed fro December 8 2014 through February 26, 2015.
 
Cadent Ltd is initiating this action after receiving a report from a customer that a single box of disposable Scanner Sleeves contained visible contamination that occurred during the manufacturing and assembly process.  No injuries or adverse events have been reported to date and a detailed risk analysis determined that there is no expected health risk to patients or healthcare workers.
 
Customers who have the following iTero disposable Scanner Sleeves for use with their iTero HDU intraoral scanner wand should stop using them immediately and return any unused sleeves for credit to their dealer along with the enclosed response form.
 
Customers with questions may contact iTero customer support 1-800-577-8767 or via e-mail at iterosupport@alligntech.com.  Product quality is a top priority and the company takes this situation very seriously.  We apologize for any inconvenience this notification may cause you and your practice.

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