by
Barbara Kram, Editor | January 23, 2008
Stryker's Trident ceramic
hip was mentioned in
an FDA warning letter
The FDA has issued a stern warning letter to Stryker regarding faulty hip implants manufactured at the company's Mahwah, NJ facility. The FDA cited "recurrence of nonconforming product and other quality problems" that led to complications, sometimes requiring revision surgeries for hip replacement patients.
However, the company indicated it "does not believe there is any clinical evidence to indicate that the products mentioned in the Warning Letter present a safety issue to patients."
The company is also in the process of responding to an earlier FDA warning about problems at its manufacturing facility in Ireland.
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Read the FDA Letter:
http://www.fda.gov/foi/warning_letters/s6627c.htm
Read Stryker's Response:
http://phx.corporate-ir.net/phoenix.zhtml?c=118965&p=irol-newsArticle&ID=1098406&highlight=
