Events

Recall of Device Recall Codman ICP Skull Bolt Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Codman & Shurtleff, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61205
  • Event Risk Class
    Class 2
  • Event Number
    Z-1279-2012
  • Event Initiated Date
    2012-02-09
  • Event Date Posted
    2012-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107558
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, monitoring, intracranial pressure - Product Code GWM
  • Reason
    Codman icp skull bolt wrench is out of specification and cannot be used to turn the screw on the drill.
  • Action
    Codman issued "Urgent - Voluntary Product Recall Notification" letters on 2/9/12 via Fedx in the US and requested accounts examine inventory and return product. An Acknowledgement Form was requested to be returned. Outside the US affiliates were notified to recall to their accounts. Questions were directed to Customer Service (800) 225-0460.

Device

Device Recall Codman ICP Skull Bolt Kit
  • Model / Serial
    Lot Numbers: CMJB1B CMJB1C CMJB1D CMJB67 CMJB68 CMJB69 CMJB7B CMJCR6 CMJCR7 CMJCR8 CMJC1F CMJC1G CMJC1H CMJC1J CMJC1K CMJC1L CMJC1M CMKBKF CMKBKG CMKBKH CMKBK3 CMKBK4 CMKBK5 CMKBK6 CMKBK7 CMKBZ3 CMKBZ4 CMKBZ5 CMKBZ6 CMKBZ7 CMKB2Y CMKB2Z CMKB20 CMKB8L CMKCKG CMKCKH CMLBH6 CMLBMY CMLBMZ CMLBM0 CMLBM1 CMLB5P CMLB5R CMLCJR CMLCJT CMLCJV CMLC5G CMLC5H CMLC5J CMMBFR CMMBFT CMMBL5 CMMBL6 CMMCF3 CMMCF4 CMMCF5 CMMCF6 CMMC4H CMMC4J CMMC4K CMMC4L CMMC4M CMNBD9 CMNBZ4 CMNBZ5 CMNBZ6 CMNBZ7 CMNBZ8 CMNCHY CMNCHZ CMNCLW CMNCLY CMNCLZ CMNCL0 CMNCL1 CMNCL2 CMNCW5 CMNCW6 CMNCW7 CMLBJH CMMBD9 CMMCFC CMNCC1 CMNCC2
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, and the countries of Canada, Austria, Brazil, Belgium, Columbia, China, Denmark, Estonia, Spain, Finland, France, Great Britain, Germany, India, Italy, Japan, Lithuania, Netherlands, New Zealand, Oman, Mexico, Portugal, Russia, Singapore, SIovenia, and Switzerland.
  • Product Description
    Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for gaining access to the cranium to allow for insertion and retention of intracranial cranial pressure sensor, included in the kit.
  • Manufacturer
    Codman & Shurtleff, Inc.

Manufacturer

Codman & Shurtleff, Inc.
  • Manufacturer Address
    Codman & Shurtleff, Inc., 325 Paramount Drive, Raynham MA 02767
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA