Devices

Device Recall DURAGEN II DURAL REGENERATION MATRIX

Model / Serial
Catalog Number DURS3391; Lot number 1091575
Product Classification
Neurological Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide distribution:Ca, NY, TX, CO, VA, SC, IA, MO, IL, LA, OR, OH, WI, FL, DC, DE, MD, MN.
Product Description
Suturable DuraGen Dural Regeneration Matrix; || Non-Pyrogenic; || Sterility guaranteed unless package is damaged or opened. Rx only. || Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536 || Suturable DuraGen is an absorbable implant for repair of dural defects. It is indicated as a dural substitute for the repair of dura matter.
Manufacturer
Integra LifeSciences Corp
1 Event
- Recall of Device Recall DURAGEN II DURAL REGENERATION MATRIX

Manufacturer

Integra LifeSciences Corp

Manufacturer Address
Integra LifeSciences Corp, 105 Morgan Ln, Plainsboro NJ 08536-3339
Manufacturer Parent Company (2017)
Integra LifeSciences Holdings Corporation
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)