Z-0695-2019 Class II Terminated
FDA device recall Z-0695-2019 was initiated by Ethicon Endo-Surgery Inc on Dec 7, 2018 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated Apr 29, 2020). Affected quantity: 480 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 16, 2019
- Initiation Date
- Dec 7, 2018
- Termination Date
- Apr 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 480 units
Product Description
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.
Reason for Recall
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
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.
Code Information
Lot Codes: P9461W, P94K20
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0695-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026