Device product
NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
Z-1440-2015
Product summary
- Event
- Event 70821
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38 units
- Official record key
device-enforcement:Z-1440-2015
Official wording
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Code information: Batch No. 13010296
Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Sweden, Turkey, and United Arab Emirates.
Derived failure modes
-
Unknown
A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.