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Terminated

Stryker brand End Cutter Shaver Blade F-Series, 4.0 mm; Model Number -375-747-000, manufactured by Stryker Puerto Rico

FDA Recall Z-0825-2011 · Posted 2010-12-28

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHRX
Date Initiated2009-11-12
Date Terminated2011-01-03
Product Quantity295 units

Reason for Recall

Potential breakage of the internal shaft of the End Cutter Shaver Blade; F-Series, 4.0mm. if breakage occurs, the device becomes non-functional and the defect could be observed through the camera/console system.

Firm Action

Stryker issued Urgent Product Recall letters dated November 12, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the product to Stryker. Stryker can be contacted concerning this recall at 408 754-2124.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution includes: Arizona, California, Colorado, Denver, Florida, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Michigan, New York, Ohio, and South Carolina.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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