Recall Z-1279-2012 ยท GWM Device, Monitoring, Intracranial Pressure
Codman & Shurtleff, Inc.
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.
| Date | Mar 22, 2012 (initiated Feb 9, 2012) |
| Status | Terminated |
| Reason | Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974088 | CODMAN INTRACRANIAL BOLT Johnson & Johnson Professionals, Inc., Jan 9, 1998 |