Device product
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.
Z-2375-2016
Product summary
- Event
- Event 74782
- Status
- Terminated
- Classification
- Class II
- Quantity
- 231 kits
- Official record key
device-enforcement:Z-2375-2016
Official wording
Reason: Incorrect drill protocol in the Instructions for Use (IFU)
Code information: Article 38072-all lots
Distribution pattern: Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.
Derived failure modes
-
Unknown
Incorrect drill protocol in the Instructions for Use (IFU)