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U.S. Department of Health and Human Services

Class 2 Device Recall Codman

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 Class 2 Device Recall Codmansee related information
Date Initiated by FirmOctober 25, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on May 29, 2015
Recall NumberZ-0709-2012
Recall Event ID 60362
510(K)NumberK853770 
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
ProductCodman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw,, Adult Product Code:80-1196 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures.
Code Information Lot codes: 449269 459957 BY254 FA247 KA209 LB283 
FEI Number 3002947440
Recalling Firm/
Manufacturer		 Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham MA 02767
For Additional Information Contact
508-880-8100
Manufacturer Reason
for Recall		Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.
FDA Determined
Cause 2		Labeling Change Control
ActionCodman issued an Urgent Medical Device Correction Notice dated October 25, 2011 to all affected customers. The notice identified the product, problem, and actions to be taken. Customers were instructed to notify all appropriate personnel of the correction notice. The notice instructs customers to fax the attached acknowledgement form to 508-977-6403. For questions call your Customer Service or contact your local Codman representative.
Quantity in Commerce462 units
DistributionWorldwide Distribution - USA (nationwide) and the countries of: Dubai, Mexico, Panama, Spain and Uruguay.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = GWM
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