|
|
Article: Stryker Orthopedics.(MEDICAL DEVICES)
- Article from:
- Warning Letter Bulletin
- Article date:
- January 1, 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)
|
Kalamazoo, MI, Nov. 28 (Parsippany, NJ)
An inspection conducted June 1-July 12, 2007, found the facility out of conformity with GMP requirements of the Quality System (QS) regulation.
The firm received continual complaints from January of 2005 through May of 2007 concerning Trident Hemispherical and Trident PSL cups that have failed to function, and concerning hip implant components that have poor fixation. In some instances, these problems have required revision surgeries.
In addition, complaints were also received between January of 2005 through April of 2007 for squeaking noises of hip implants with ceramic bearing components; some of those ...