Recall Z-0695-2019— Ethicon Endo-Surgery Inc
Class II · Terminated
Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2018-12-07, terminated 2020-04-29. It names one FDA 510(k) clearance: K030925. 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.. 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.
- Recalling firm
- Ethicon Endo-Surgery Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-07
- Terminated
- 2020-04-29
- Firm location
- Blue Ash, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.