|
|
Article: FDA faults device maker for defective artificial hips.(Medical Devices)(Brief article)
- Article from:
- Adverse Event Reporting News
- Article date:
- January 29, 2008
CopyrightCOPYRIGHT 2008 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
Stryker Orthopedics has been cited in an FDA warning letter for making defective artificial hip implants that resulted in pain, fractures and, in some cases, additional surgery for patients.
In a Warning Letter issued Nov. 28, FDA pointed to hip replacements that did not meet quality standards, and chastised the company for failing to identify and fix problems in both its manufacturing and oversight processes despite a stream of complaints over a two-year period. The letter reads:
"Your firm has failed to implement adequate corrective and preventive actions in order to prevent recurrence of nonconforming product and other quality problems," FDA wrote.
...