Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Synthes Charged With Unauthorized Spine Repair Trial, Faces $34 Mil. Fine

This article was originally published in The Gray Sheet

Executive Summary

Orthopedic device maker Synthes and its Norian subsidiary face $34.8 million in potential fines for allegedly skirting FDA requirements and conducting unauthorized clinical trials of their Norian XR and Norian SRS bone cement for vertebral compression fractures
Advertisement

Related Content

Synthes To Pay $23 Million For Illegal Testing, Marketing Scheme
Synthes To Pay $23 Million For Illegal Testing, Marketing Scheme
FDA Targeting Execs With Criminal Charges For Adulterated/Misbranded Goods
FDA Targets Executives With Powerful Misdemeanor Strategy
Prosecuting "Responsible" Execs: FDA Brandishes Powerful Legal Weapon
Synthes guilty pleas
Orthovita Touts Cortoss As Alternative To Cement For Vertebral Fractures
New Jersey Attorney General Targets Industry Ties To Clinical Investigators
Synthes Bone Void Filler Off-Label Concerns, MDR Gaps Elicit FDA Warning
Synthes Bone Void Filler Off-Label Concerns, MDR Gaps Elicit FDA Warning

Topics

Advertisement
UsernamePublicRestriction

Register

MT027586

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel