Straumann Manufacturing, Inc. recalls Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental impl…

Recall date

November 23, 2016

Source

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

Recall number

Z-0958-2017

FDA classification

Class II

Brand / firm

Straumann Manufacturing, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

Drills cannot be inserted into handpiece due to tolerance specification not met

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

What was recalled

Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function