Z-0696-2019 Class II Terminated
FDA device recall Z-0696-2019 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: 15,264 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
- 15,264 units
Product Description
PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease
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: P93K95 P9420Y P94A4T P93L1M P9420Z P94D3N P93M3G P9441H P94F3Z P93T35 P9450L P94G04 P93T7F P9463J P94H5F P93W3M P94765 P94J4W P93W3N P9487Z P94J80 P93Y58 P94901 P94K2A P94117 P94A20 R9200Z
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0696-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026