Events

Recall of Device Recall ContraAngles CA1:1L EVO 15

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bien Air Dental SA.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72079
  • Event Risk Class
    Class 2
  • Event Number
    Z-2797-2015
  • Event Initiated Date
    2015-08-27
  • Event Date Posted
    2015-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139729
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Handpiece, contra- and right-angle attachment, dental - Product Code EGS
  • 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

Device

Device Recall ContraAngles CA1:1L EVO 15
  • Model / Serial
    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
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US distribution to one distributor in FL.
  • Product Description
    Contra-Angles CA1:1L EVO 15 || Catalog numbers: 1600939-001 and 1600938-001 || Used for generally dentistry procedures
  • Manufacturer
    Bien Air Dental SA

Manufacturer

Bien Air Dental SA
  • Manufacturer Address
    Bien Air Dental SA, Langgasse 60, Biel/bienne Switzerland
  • Manufacturer Parent Company (2017)
    Bien-Air Holding Sa
  • Source
    USFDA