Recall Z-0458-2009 ยท JXG Shunt, Central Nervous System And Components
Integra LifeSciences Corp.
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 appr
| Date | Dec 12, 2008 (initiated Oct 3, 2008) |
| Status | Terminated |
| Reason | Integra NeuroSciences has become aware that certain Gravity Compensating Accessory implants have the potential for CSF leakage under certain conditions. |
| Root cause | Process control |
| 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 |
| Quantity | 49 units |
| Distribution | Worldwide Distribution - MI, IL, NY, IN, CA, IN and NC and Carnegie, Victoria, Melbourne, Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932429 | CORDIS GRAVITY COMPENSATING ACCESSORY Cordis Corp., Jul 20, 1994 |