Device Recall ContraAngles CA1:1L EVO 15 의 리콜

Recall

72079

Class 2

Z-2797-2015

2015-08-27

2015-09-21

Terminated

United States

2016-03-31

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139729

Possible loosening of the dental tool, which may lead to potential swallowing of the tool.

Bien Air Dental sent an Urgent Medical Device Safety Alert on August 27, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the mentioned device. The letter requests that customers inspect their inventory for the product those and affected within the scope, and immediately quarantine them. The firm states to fill out the attached REPLY FORM and returned it fax to +41 32 344 64 91. If customers have further distributed any of the subject devices to other organizations, please forward this note to them immediately, to stop using the affected devices and to place them in quarantine. All the devices at customer or end-user locations shall be also returned to Bien Air. Please return the affected products to Bien-Air Dental (the exact address for return will be communicated to you via Bien-Air Sales Manager). A Bien-Air Sales Manager will also be in contact with customers. Upon receipt of the completed REPLY FORM, a Bien-Air Dental Representative will contact customers to arrange for the return and/or replacement of any non-conforming units. Should customers require any further information or have any queries on the matter please contact Bien-Air Dental SAs Regulatory Affairs at: +41 32 344 6464