Codman Disposable Plastic Intracranial Press/Kit

• 3 recalls, same reason

  • Terminated Z-0708-2012 FDA Unclassified (pre-2012) ·initiated 25 Oct 2011
  • Terminated Z-0709-2012 FDA Unclassified (pre-2012) ·initiated 25 Oct 2011
  • Terminated Z-0710-2012 FDA Unclassified (pre-2012) ·initiated 25 Oct 2011

  Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.

• 2 recalls, same reason

  • Terminated Z-2029-2011 FDA Unclassified (pre-2012) ·initiated 30 Nov 2010
  • Terminated Z-2031-2011 FDA Unclassified (pre-2012) ·initiated 30 Nov 2010

  Packaging defect may compromise sterility of device

510(k) Number

K853770 ↗

FDA Product Code

GWM

Device Class

Class II

Regulation

21 CFR Part 882.1620

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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