Article: Stryker Orthopedics.(MEDICAL DEVICES)

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 ...

Related newspaper, magazine, and journal articles:

 
 
Newsweek Harper's Magazine The Washington Post Chicago Tribune Crain's Chicago Business PRNewswire Pediatric News The Nation Advertising Age The Economist (US) A FREE trial gives you access to over 80 million articles! Access over 6,500 publications with a FREE trial!