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U.S. Department of Health and Human Services

Class 1 Device Recall GCA (Gravity Compensating Accessory)

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 Class 1 Device Recall GCA (Gravity Compensating Accessory)see related information
Date Initiated by FirmOctober 03, 2008
Date PostedDecember 12, 2008
Recall Status1 Terminated 3 on October 06, 2009
Recall NumberZ-0458-2009
Recall Event ID 50065
510(K)NumberK932429 
Product Classification Central Nervous System Fluid Shunt and Components - Product Code JXG
ProductGravity Compensating Accessory; High Pressure Range, Sterile, Single Use, Rx only. CSF shunt accessory. Manufacturer: Integra Neuro Sciences Implants, SA, Cedex, France; distributed by: Integra NeuroSciences, Plainsboro, NJ 08536 The GCA is an implantable device designed to be used in conjunction with implanted systems which shunt cerebrospinal fluid CSF from the cerebral ventricles to an appropriate drainage site.
Code Information Catalog number: 903-430, Lot Numbers 148792, 149247; Catalog Number 903-435, Lot Numbers 147796, 148790; Catalog Number 903-440; and Lot Numbers 147795, 149246
FEI Number 3003418325
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information ContactDavid Uffer
609-275-0500
Manufacturer Reason
for Recall		Integra NeuroSciences has become aware that certain Gravity Compensating Accessory implants have the potential for CSF leakage under certain conditions.
FDA Determined
Cause 2		Process control
ActionUrgent: Product Recall Notification letters, dated 10/3/08, were sent out on October 9, 2008. Letters explain the reason for the recall and the catalog and lot numbers affected. If the product has been implanted, it is recommended that the patient be monitored periodically using the standard of care determined appropriate by the patient's attending physician. If the product is found in inventory, customers are asked to quarantine the product and contact their Integra Sales Rep for assistance and for arrangements for product return. A Recall Acknowledgement and Return Form is to be completed and returned to Integra for reconciliation purposes.
Quantity in Commerce49 units
DistributionWorldwide Distribution - MI, IL, NY, IN, CA, IN and NC and Carnegie, Victoria, Melbourne, Australia.
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 = JXG
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