Synthes in-Situ Bender/Cutter

• • Terminated Z-0825-2010 FDA Unclassified (pre-2012) ·initiated 6 Jan 2010

  There is the potential for the bender/cutter attachment to continue heating after release of the power button. There is potential for patient and/or staff injury if continuous heating is unrecognized.

• 2 recalls, same reason

  • Terminated Z-1640-2009 FDA Unclassified (pre-2012) ·initiated 3 Apr 2009
  • Terminated Z-1641-2009 FDA Unclassified (pre-2012) ·initiated 3 Apr 2009

  Sterility may be compromised due to a ineffective package design.

• 2 recalls, same reason

  • Terminated Z-1248-2009 FDA Unclassified (pre-2012) ·initiated 18 Dec 2008
  • Terminated Z-1249-2009 FDA Unclassified (pre-2012) ·initiated 18 Dec 2008

  The bender is heating prior to activation of the power button, requiring disassembly to stop heating.

510(k) Number

K021458 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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