BEUDAMED
    FDA Recall Terminated

    Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

    Recall: Z-2797-2015 · Initiated August 27, 2015

    Recall

    Recall Number
    Z-2797-2015
    Event Number
    72079
    Firm
    Bien Air Dental SA Langgasse 60 Biel/bienne Switzerland
    FEI Number
    3002762033
    Product Code
    EGS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 27, 2015
    Posted
    September 21, 2015
    Terminated
    March 31, 2016

    Description

    Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

    Reason

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

    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

    Distribution

    Worldwide Distribution - US distribution to one distributor in FL.

    Quantity

    112 (U.S.)