Ethicon Endo-Surgery Inc recalls PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code:
Recalled Product
PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
Hazard / Issue
Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired
Issued by
FDA
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