FDA Medical Device Recalls (openFDA)
Bien Air Dental SA: Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
- Recall number
- Z-2797-2015
- Recalling firm
- Bien Air Dental SA
- Product
- Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
- Status
- Terminated
- Initiated
- 2015-08-27
- Posted
- 2015-09-21
- Terminated
- 2016-03-31
- Reason
- Possible loosening of the dental tool, which may lead to potential swallowing of the tool.
- Root cause
- Other
- 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
- 112 (U.S.)
- Distribution
- Worldwide Distribution - US distribution to one distributor in FL.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EGS
- Firm FEI
- 3002762033
- Firm city
- Biel/bienne
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28