Patient Safety Member Alert

Stryker issues voluntary recall of Trident® Hemispherical Shells

On Jan. 28, 2008, the AAOS issued the following Patient Safety Member Alert:

Stryker Orthopaedics has issued a voluntary recall of all Trident® Hemispherical Shells manufactured at their Cork, Ireland, facility between January 2000 and December 2007. The recall, initiated by Stryker on January 21, 2008, is in response to a recent cleaning process evaluation conducted at the Cork, Ireland, facility that revealed that some parts tested exceeded the internal acceptance criteria for manufacturing residuals. The result of exceeding these manufacturing residuals values presents the potential hazard that the device may not achieve biological fixation.

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