Straumann Manufacturing, Inc.: Drills cannot be inserted into handpiece due to tolerance specification not met

Agency Publication Date: January 6, 2017

Affected Products

Product: 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

Lot Number: LV463, MG783, MH027

Lot Numbers:

Number

Product: 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

Lot Number: LV455

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75983

Status: Resolved

Manufacturer: Straumann Manufacturing, Inc.

Manufactured In: United States

Units Affected: 2 products (165 units; 120 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot Number: LV463, MG783, MH027

Lot Numbers:

Number

Lot Number: LV455

Lot Numbers:

Number