Z-1279-2012

Codman ICP Skull Bolt Kit

Name: Z-1279-2012 Codman ICP Skull Bolt Kit
Creator: Codman & Shurtleff, Inc.
Published: 2012-02-09
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2012-02-09 / Terminated / root cause: manufacturing process

FDA source

Codman & Shurtleff, Inc. began a recall of 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... on 2012-02-09. The reason FDA records is "Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1279-2012
Status: Terminated
Initiated: 2012-02-09
Posted: 2012-03-22
Terminated: 2015-09-11
Recalling firm: Cerenovus, Inc.
Product: 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.
Product code: GWM Device, Monitoring, Intracranial Pressure
Reason for recall: Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 4056 kits
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 codes and lots: 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 code GWM

K974088Class IICodman Intracranial BoltJohnson & Johnson Professionals, Inc. / cleared 1998-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)