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U.S. Department of Health and Human Services

Class 2 Device Recall ContraAngles CA1:1L EVO 15

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  Class 2 Device Recall ContraAngles CA1:1L EVO 15 see related information
Date Initiated by Firm August 27, 2015
Date Posted September 21, 2015
Recall Status1 Terminated 3 on March 31, 2016
Recall Number Z-2797-2015
Recall Event ID 72079
Product Classification Handpiece, contra- and right-angle attachment, dental - Product Code EGS
Product Contra-Angles CA1:1L EVO 15
Catalog numbers: 1600939-001 and 1600938-001
Used for generally dentistry procedures
Code Information Catalog numbers: 1600939-001 and 1600938-001 Serial numbers concerned: - Ref: 1600939-001: Serial numbers included in the following range: 15B0001 up to 15F0011 - Ref: 1600938-001: Serial numbers included in the following range: 15B0007 up to 15F0027 
Recalling Firm/
Bien Air Dental SA
Langgasse 60
Biel/bienne Switzerland
Manufacturer Reason
for Recall
Possible loosening of the dental tool, which may lead to potential swallowing of the tool.
FDA Determined
Cause 2
Action 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
Quantity in Commerce 112 (U.S.)
Distribution Worldwide Distribution - US distribution to one distributor in FL.
Total Product Life Cycle TPLC Device Report

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.