Device product
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
Z-2797-2015
Product summary
- Event
- Event 72079
- Status
- Terminated
- Classification
- Class II
- Quantity
- 112 (U.S.)
- Official record key
device-enforcement:Z-2797-2015
Official wording
Reason: Possible loosening of the dental tool, which may lead to potential swallowing of the tool.
Code information: 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
Distribution pattern: Worldwide Distribution - US distribution to one distributor in FL.
Derived failure modes
-
Unknown
Possible loosening of the dental tool, which may lead to potential swallowing of the tool.