Lanx Fusion System- SA

• • Terminated Z-0400-2014 FDA Class II ·initiated 4 Nov 2013

  Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized.

• • Terminated Z-0982-2015 FDA Class II ·initiated 22 Aug 2013

  The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly.

• • Terminated Z-0978-2015 FDA Class II ·initiated 22 Aug 2013

  The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft.

• • Terminated Z-0983-2015 FDA Class II ·initiated 22 Aug 2013

  The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve.

510(k) Number

K123767 ↗

FDA Product Code

OVD

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Lanx Spinal Fixation System

  Class II

  FDA 510(k) K043484 Active Cleared 16 May 2005

• Modification to Lanx Posterior Cervicothoracic Spinal Fixation System

  Class II

  FDA 510(k) K100888 Active Cleared 15 Nov 2010

• Lanx Cervical Intervertebral Body Fusion System

  Class II

  FDA 510(k) K103660 Active Cleared 28 Feb 2011

• Lanx Anterior Cervial Plate System

  Class II

  FDA 510(k) K040401 Active Cleared 12 Apr 2004

• Lanx Anterior Plating System

  Class II

  FDA 510(k) K092765 Active Cleared 7 Apr 2010

• Lanx Posterior Cervicothoracic Spinal Fixation System (Pcfs)

  Class II

  FDA 510(k) K113434 Active Cleared 19 Dec 2011

See all devices from Lanx, Inc. →