Recall Z-2375-2016 ยท DZI Drill, Bone, Powered
Nobel Biocare Usa Llc
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
| Date | Jul 20, 2016 |
| Status | Terminated |
| Reason | Incorrect drill protocol in the Instructions for Use (IFU) |
| Root cause | Labeling design |
| Action | The firm, Nobel Biocare, sent "IMPORTANT-QUALITY MESSAGE" Field Correction Letters and response forms dated July 22, 2016. The letter describes the product, problem and actions to be taken and informs the customers that the titles of the IFU and the Manual are "NobelGuide for NobelParallel Conical Connection" (ID number 2002) and "Guided Surgery with Nobel Parallel Conical Connection" (ID number 79423). The Customers are instructed to review if you have a printed version of the IFU or the Manual related to the article and discard them; and to complete the attached "Quality Message Acknowledg |
| Quantity | 231 kits |
| Distribution | Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990846 | AMORPHOUS DIAMOND COATED DRILL Nobel Biocare Uas, Inc., Jun 10, 1999 |