—#74612

Product

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.

FDA product code: JXG — Shunt, Central Nervous System And Components
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K932429
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

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

Timeline

Recall initiated: 2008-10-03
Posted by FDA: 2008-12-12
Terminated: 2009-10-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74612. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.