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Stryker Hip Replacement Recall

October 15th, 2012

Stryker Manufacturing Practices Questioned

Concerns about Stryker Orthopaedics hip replacement products began in 2005, two years after the Trident Acetabular Cup System, a hip implant system, was approved and released to the market. Patients started complaining about the squeaking noises of their Stryker hip replacements and the improper seating of their hip replacements causing bone fractures, so the FDA took action. After inspecting the Stryker Ireland manufacturing plant and finding a lack of conformity with Current Good Manufacturing Practice (CGMP), the FDA issued a warning letter to the company on March 15, 2007. The warning said the facility was failing to establish and maintain adequate procedures for fixing products and analyzing risks.

A second warning was issued by the FDA on November 28, 2007, following another inspection—this time of the company’s New Jersey plant. Once more, the FDA brought attention to the fact that the company had failed to establish procedures for identifying and correcting nonconforming products and addressing other quality problems.

For more information about the Stryker hip implant recall and your legal options, visit www.seegerweiss.com/stryker-hip-recall.



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