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Stryker Says FDA Warnings From 2007 Addressed

Wed, 03/24/2010 - 5:20am

KALAMAZOO, Mich. (AP) — The Food and Drug Administration has told Stryker Corp. that it has taken sufficient action to fix problems at its facility in Mahwah, N.J., the medical implant maker said Tuesday.

The company received a warning letter in 2007 from the FDA after a six-week inspection of the facility, which houses manufacturing operations, research and development and administrative offices.

Later, federal regulators ordered the company to fix a host of long-standing problems in its manufacturing of hip replacement parts, which triggered multiple patient complaints and forced some patients to have follow-up surgeries.

Problems included improper fitting of hip implants that caused bone fractures. Patients had also complained about pain, difficulty walking, squeaky joints and uneven wear or breaking of implant parts.

Some parts of the facility were found to be contaminated with disease-causing germs, including "clumps and clusters" of a form of Staphylococcus bacteria.

The company said Tuesday that after a follow-up inspection by the FDA in 2009 and additional corrective actions, it was informed the issues had been adequately addressed and no further formal corrective actions were required.

The resolution of the issues "is another important step in demonstrating our firm commitment to significantly transforming our quality systems," CEO Stephen MacMillan said in a statement.

"The investments we have made, and will continue to make, are resulting in solid progress toward our goals," he said.

 

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