FDA-Device2019-04-03Class II

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

Keystone Dental Inc
Hazard

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

Sold states
FL, MA, SC, VA
Affected count
1 hex Driver
Manufactured in
154 Middlesex Tpke, N/A, Burlington, MA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1062-2019

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief