Non-Rotating Gold Cylinder and Screw

• • Terminated Z-1956-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009 ·on shared 510(k) K874400

  Biomet 3i, Palm Beach Gardens, FL is recalling their Gold Slotted Retaining Screw 3MM, Model Number GS300. Product is Out Of Specification - product was manufactured with a material not specified for use in this product.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K874400 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• G-Floss & G-Floss II

  Class I

  FDA 510(k) K911701 Active Cleared 15 May 1991

• Abutment Glo

  Class I

  FDA 510(k) K905303 Active Cleared 10 Jun 1991

• Implant Innovation Pre-Angled Abutment System

  Class II

  FDA 510(k) K932123 Active Cleared 27 May 1994

• Abutment Head Post

  Class II

  FDA 510(k) K871954 Active Cleared 31 Jul 1987

• Adbutment Cylinder and Screw

  Class II

  FDA 510(k) K871863 Active Cleared 10 Jul 1987

• Post. Screw & Hex Driver/Adbut & Adbut Head Driver

  Class II

  FDA 510(k) K871862 Active Cleared 10 Jul 1987

See all devices from Implant Innovations International, Inc. →