Gravity Compensating Accessory; High Pressure Range, Sterile, Single Use, Rx only. CSF shunt accessory. Manufacturer: In
FDA device recall Z-0458-2009 · posted 2008-12-12 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Integra NeuroSciences has become aware that certain Gravity Compensating Accessory implants have the potential for CSF leakage under certain conditions.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 49 units
- Distribution
- Worldwide Distribution - MI, IL, NY, IN, CA, IN and NC and Carnegie, Victoria, Melbourne, Australia.
- Date initiated
- 2008-10-03
- Date posted
- 2008-12-12
- Date terminated
- 2009-10-06
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORDIS GRAVITY COMPENSATING ACCESSORY (K932429) | Cordis Corp. | 1994-07-20 |