Leveen Needle Electrode

• • Terminated Z-0079-2013 FDA Class II ·initiated 17 Sep 2012

  Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.

• 2 recalls, same reason

  • Terminated Z-1876-2009 FDA Unclassified (pre-2012) ·initiated 6 Jul 2009
  • Terminated Z-1877-2009 FDA Unclassified (pre-2012) ·initiated 6 Jul 2009

  The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.

510(k) Number

K000032 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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