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Stryker Corporation has recalled two Trident hip implant products because of manufacturing problems at the company’s Cork, Ireland plant.
The recalled products include Trident PSL and Hemispherical Acetabular Cups. According to the voluntary recall, the parts could be contaminated with “manufacturing residuals.”
FDA Warning
A week before the recall was announced, Stryker had received a warning from the Food and Drug Administration regarding problems at the company’s Mahwah, New Jersey facility.
The FDA warning cited patient complaints dating as far back as January 2005 about a variety of problems, including bone fractures caused by ill-fitting hip implants. Some patients have reported having to undergo follow-up surgeries.
Implant parts made at the N.J. plant were not included in the recall.
(Source: BusinessWeek)
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