Device product
Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
Z-1062-2019
Product summary
- Event
- Event 82374
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 hex Driver
- Official record key
device-enforcement:Z-1062-2019
Official wording
Reason: Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
Code information: Lot Numbers: WO-010366
Distribution pattern: FL, MA, SC, VA
Derived failure modes
-
Unknown
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature