Reflex Hybrid Acp System

• 2 recalls, same reason

  • Terminated Z-0762-2010 FDA Unclassified (pre-2012) ·initiated 12 Oct 2009
  • Terminated Z-0763-2010 FDA Unclassified (pre-2012) ·initiated 12 Oct 2009

  The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.

510(k) Number

K062310 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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