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Stryker Cork recall | Stryker Cork recall |
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| Written by Mary O’ Keeffe | |
| Thursday, 24 January 2008 | |
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Stryker Corporation has announced that it is voluntarily recalling two products manufactured at its Cork facility. The plant, based at Carrigtwohill manufactures orthopaedic products including hip and knee replacements. The recall follows on from a warning letter the company received last November from the United States Food and Drug Administration (FDA) which said that results from testing at the plant had indicated that the level of "manufacturing residuals" in some cases actually exceeded the company's own internal acceptance criteria. In a statement, Stryker Corp said that as a result of a comprehensive review of internal processes following the FDA's observations, it conducted an investigation into this deviation and is initiating a voluntary recall of their Trident PSL and Hemispherical Acetabular cups, (hip-joint products) made at the Carrigtwohill facility. It stressed that the company does not believe there is any clinical evidence to indicate that the products present a safety issue to patients and that numerous published independent reports validate the long term clinical performance of these products. The company said that it now expects some short-term supply disruption as a result of the recall and is focused on eliminating these disruptions as quickly as possible. To this end, it said that production had now been increased at the facility as well as at their Mahwah plant. Stryker added that it did not anticipate any material financial impact on Stryker's guidance for its 2008 results as a result of the voluntary recall. |
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