Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for gaining access to the cranium to
FDA device recall Z-1279-2012 · posted 2012-03-22 · Terminated
Recall details
- Recalling firm
- Codman & Shurtleff, Inc.
- Reason for recall
- Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill
- Action taken
- 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
- Status
- Terminated
- Product code
- GWM
- Quantity affected
- 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,
- Date initiated
- 2012-02-09
- Date posted
- 2012-03-22
- Date terminated
- 2015-09-11
- Location
- Raynham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CODMAN INTRACRANIAL BOLT (K974088) | Johnson & Johnson Professionals, Inc. | 1998-01-09 |