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The Stryker Corporation’s recall of its Trident PSL and Hemispherical Acetabular Cups has caused confusion amongst patients trying to understand which products were recalled, what risks are involved and what occurred at the company’s manufacturing facilities. Here are some answers that might help patients understand the recall:

What products were recalled?

Stryker recalled its Trident PSL and Hemispherical Acetabular Cups. The products are used in hip replacement surgery. Trident is Stryker’s brand name and their PSL version is the most commonly used cups in the United States. The Trident system uses alumina ceramic on ceramic materials instead of traditional metal on metal or metal on plastic materials. The company manufactures these products in at least two facilities – New Jersey and Ireland. Only products manufactured in Ireland are part of the recall.

For additional information on these products, see the company’s website at www.stryker.com and look under products.

Why were the products recalled?

The products were voluntarily recalled by Stryker after concerns arose in their Cork Ireland facility regarding sterility. Specifically, the company reported that ‘manufacturing residual’ levels were higher than ‘internal specifications’.

Are patients at risk?

Stryker says no. Although the company admitted that there were issues concerning the sterility of the products manufactured in Ireland, it said that:

It is important to note this in no way impacts the product's sterility, nor product conformance to U.S. and international biocompatibility standards. . . . Medical expert opinion of current and historical data concludes that there are no safety issues for patients who received these products.

What happened at the New Jersey facility?

The FDA spent six weeks at Stryker’s Mahwah New Jersey facility in June 2007 and found that the company was not addressing several issues. It sent Stryker a letter on November 28, 2007 (not made public until January 15, 2007) outlining areas of product deficiency, contamination and consumer complaints. The FDA’s letter was stern and warned Stryker that it must address these issues or face severe penalties. It is yet unknown what, if anything, Stryker has done to address these issues in its New Jersey facility.

What happened at the Ireland facility?

One day after the FDA’s letter was made public; Stryker issued a press release saying that it had concerns about sterility issues in its Cork Ireland facility. Less than a week later, it issued the product recall.

When did Stryker know about these problems?

According to the FDA’s warning letter (www.fda.gov/foi/warning_letters/s6627c.htm), Stryker has known about consumer complaints and product and facility issues since 2005. While the company has responded to previous FDA letters concerning the issues, the FDA claims that Stryker has ‘failed to establish and maintain procedures’ in many areas that conform to FDA guidelines and has not adequately addressed consumer complaints.

What should patients do?

Unfortunately, that’s a question that has yet to be determined. Since Stryker is saying that the recalled products don’t pose any danger, patients don’t really know what to do. Those with concerns should:

• See their doctor, find out where their components were manufactured and discuss what to do.
• Contact the company. Patients can contact the company at:
  2825 Airview Boulevard
  Kalamazoo, MI 49002
  Customer service number: 269 385 2600
• Consult with an attorney. To consult with a qualified attorney who is following the Stryker recall and whose practice focuses in this area of law, please click here. There is no obligation and the consultation is free.