Z-2797-2015Class II

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

Name: Z-2797-2015 Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry...
Creator: Bien Air Dental SA
Published: 2015-08-27
License: https://open.fda.gov/license/

Bien-Air Dental SA / initiated 2015-08-27 / Terminated

FDA source

Bien Air Dental SA began a recall of Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures on 2015-08-27. FDA classified it as Class II and gives the reason as "Possible loosening of the dental tool, which may lead to potential swallowing of the tool". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2797-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-27
Posted: 2015-09-21
Terminated: 2016-03-31
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
Product code: EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Reason for recall: Possible loosening of the dental tool, which may lead to potential swallowing of the tool.
FDA 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 in commerce: 112 (U.S.)
Distribution: Worldwide Distribution - US distribution to one distributor in FL.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2797-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2797-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-21

Product code EGS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)