Spin Down Rapidflap

• 6 recalls, same reason

  • Terminated Z-0393-2019 FDA Class II ·initiated 22 Aug 2018
  • Terminated Z-0398-2019 FDA Class II ·initiated 22 Aug 2018
  • Terminated Z-0395-2019 FDA Class II ·initiated 22 Aug 2018
  • Terminated Z-0394-2019 FDA Class II ·initiated 22 Aug 2018
  • Terminated Z-0397-2019 FDA Class II ·initiated 22 Aug 2018
  • Terminated Z-0396-2019 FDA Class II ·initiated 22 Aug 2018

  Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.

510(k) Number

K031034 ↗

FDA Product Code

GXN

Device Class

Class II

Regulation

21 CFR Part 882.5330

Advisory Committee

Neurology

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. →