Recall Z-2797-2015— Bien Air Dental SA
Class II · Terminated
Class II FDA medical device recall by Bien Air Dental SA, initiated 2015-08-27, terminated 2016-03-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Bien Air Dental SA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-27
- Terminated
- 2016-03-31
- Firm location
- Biel/bienne, N/A, Switzerland
Product description
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
Reason for recall
Possible loosening of the dental tool, which may lead to potential swallowing of the tool.
Data sourced from openFDA. This site is unofficial and independent of the FDA.