Devices

Device Recall InSpan Inserter

Model / Serial
Right Assembly: 43097, 44614, 43097R; Left Assembly: 43098, 44615, 43098R
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA Nationwide: in the states of: FL, CO, VA, KS, TX, OH, TN, OK, CA, IL, MO, MN, Wash DC, including PR and the countries of Dominican Republic, Medico, Panama
Product Description
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly || Product Usage: || Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.
Manufacturer
SpineFrontier, Inc.
1 Event
- Recall of Device Recall InSpan Inserter

Manufacturer

SpineFrontier, Inc.

Manufacturer Address
SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
Manufacturer Parent Company (2017)
SpineFrontier, Inc.
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)