Recall Z-2797-2015 ยท EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Bien Air Dental SA
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
| Date | Sep 21, 2015 (initiated Aug 27, 2015) |
| Status | Terminated |
| 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 organiz |
| Quantity | 112 (U.S.) |
| Distribution | Worldwide Distribution - US distribution to one distributor in FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.