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.
FDA Recall Z-1279-2012 · Posted 2012-03-22
Recalling FirmCodman & Shurtleff, Inc.
Recall StatusTerminated
Product CodeGWM
Date Initiated2012-02-09
Date Terminated2015-09-11
Product Quantity4056 kits
Reason for Recall
Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.