Lorenz Resorbable Distractor System

• 3 recalls, same reason

  • Terminated Z-0384-2012 FDA Unclassified (pre-2012) ·initiated 17 Feb 2006
  • Terminated Z-0383-2012 FDA Unclassified (pre-2012) ·initiated 17 Feb 2006
  • Terminated Z-0385-2012 FDA Unclassified (pre-2012) ·initiated 17 Feb 2006

  Lorenz Engineer discovered flex tube could break if bent too much.

510(k) Number

K002083 ↗

FDA Product Code

JEY

Device Class

Class II

Regulation

21 CFR Part 872.4760

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Lorenz 1.0 Mm System

  Class II

  FDA 510(k) K922741 Active Cleared 23 Dec 1992

• Lorenz 1.5 X 4 Mm Lactosorb Tap Free Screw

  Class II

  FDA 510(k) K021522 Active Cleared 21 May 2002

• Lorenz External Mandibular Distractor

  Class II

  FDA 510(k) K992873 Active Cleared 17 Sep 1999

• Steinhauser Titanium Mini Bone Plates & Screws

  Class II

  FDA 510(k) K862482 Active Cleared 25 Jul 1986

• Lorenz Pectus Support Bar

  Class II

  FDA 510(k) K972420 Active Cleared 11 Aug 1997

• Lorenz Maxilla (Le Fort) Distraction System

  Class II

  FDA 510(k) K982604 Active Cleared 23 Oct 1998

See all devices from Walter Lorenz Surgical, Inc. →