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BC hospitals may have installed prostheses from factory criticized by FDA

B.C. hospitals were allowed to install replacement hip prostheses obtained from Stryker Corporation, an American company that the US Food and Drug Administration criticized for unsanitary manufacturing conditions.

Stryker issued a recall of hip prostheses manufactured in its Cork, Ireland, plant this January.

Health Canada responded to that recall with a “Notice to Hospitals” suggesting Canadian purchasers buy prostheses produced in the company’s New Jersey plant.

But on November 28, 2007, the US Food and Drug Administration warned Stryker of perceived deficient and unsanitary conditions in its Mahwah, New Jersey plant.

How many Stryker hips have been installed by B.C. hospitals remains unknown.

"The surgeons use a variety of hip prostheses from companies such as Zimmer, Stryker, Wright Medical, DuPuy (J&J) and Biomet. I don't have the breakdown for you, but I'm told only surgeons from Vancouver Island use the Stryker products,” Gavin Wilson, a spokesman for Vancouver Coastal Health Authority told The Tyee in an e-mail.

In a subsequent telephone call, Wilson confirmed that hip surgeries performed in the VCH hospitals, including the Centre for Surgical Innovation at UBC hospital, sometimes use Stryker products.

“They are approved for use by Health Canada, so we would not, as an organization, have any objection to their use,” Wilson said.

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