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

February 22, 2019

Class II

Product summary

Firm: Keystone Dental Inc
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
reason.no_named_rule · v1.0.0

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