Microsensor Intracranial Pressure Transducer

• • Ongoing Z-1614-2023 FDA Class II ·initiated 11 Apr 2023

  Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or infection.

• 2 recalls, same reason

  • Terminated Z-0706-2012 FDA Unclassified (pre-2012) ·initiated 25 Oct 2011
  • Terminated Z-0707-2012 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.

510(k) Number

K914479 ↗

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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See all devices from Codman & Shurtleff, Inc. →