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Recall Observatory FDA recall evidence

Device 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.

Z-0695-2019

December 07, 2018

Class II

Product summary

Firm
Ethicon Endo-Surgery Inc
Event
Event 81773
Status
Terminated
Classification
Class II
Quantity
480 units
Official record key
device-enforcement:Z-0695-2019

Official wording

Reason: 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

Code information: Lot Codes: P9461W, P94K20

Distribution pattern: Worldwide Distribution: US (Nationwide) and to countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, ECUADOR, EGYPT, INDIA, INDONESIA, JAPAN, KOREA, KUWAIT, LEBANON MEXICO, NICARAGUA, PAKISTAN, SAUDI ARABIA, SINGAPORE, TAIWAN URUGUAY and VIETNAM.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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