Keystone Dental Inc recalls Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devic…

Recall date

February 22, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1061-2019

FDA classification

Class II

Brand / firm

Keystone Dental Inc

Sold / distributed

FL, MA, SC, VA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112