Z-0957-2017 Class II Terminated

Recalled by Straumann Manufacturing, Inc. — Andover, MA

Recall Details

Product Type
Devices
Report Date
January 18, 2017
Initiation Date
November 23, 2016
Termination Date
August 29, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
165 units

Product Description

Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 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

Reason for Recall

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

Distribution Pattern

Nationwide Distribution

Code Information

Lot Number: LV463, MG783, MH027