FDA recall Z-1063-2019

Keystone Dental Inc · Class II · device

Product

Paltop 1.25 Hex Drivers, Long Part Number: 60-70101

Reason for recall

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

Distribution

FL, MA, SC, VA

Key facts

Status: Terminated
Initiation date: 2019-02-22
Report date: 2019-04-03
Termination date: 2020-06-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1063-2019