Device product
Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function
Z-0958-2017
Product summary
- Event
- Event 75983
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 units
- Official record key
device-enforcement:Z-0958-2017
Official wording
Reason: Drills cannot be inserted into handpiece due to tolerance specification not met
Code information: Lot Number: LV455
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Potency or specification failure
specification not met