FDA recall Z-1062-2019

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

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-1062-2019