FDA Recall Terminated

Gravity 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.

Recall: Z-0458-2009 · Initiated October 3, 2008

Recall

Recall Number: Z-0458-2009
Event Number: 50065
Firm: Integra LifeSciences Corp.
FEI Number: 3003418325
Product Code: JXG
Status: Terminated
Root Cause: Process control
Initiated: October 3, 2008
Posted: December 12, 2008
Terminated: October 6, 2009
Address: 311 Enterprise Dr, Plainsboro, NJ, 08536-3344

Description

Reason

Integra NeuroSciences has become aware that certain Gravity Compensating Accessory implants have the potential for CSF leakage under certain conditions.

Action

Urgent: 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.

Distribution

Worldwide Distribution - MI, IL, NY, IN, CA, IN and NC and Carnegie, Victoria, Melbourne, Australia.

Quantity

49 units