Recall Z-0057-2013— Ethicon Endo-Surgery Inc
Class I · Terminated
Class I FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2012-08-03, terminated 2013-07-12. It names 4 FDA 510(k) clearances: K051301, K030925, K030411 and 1 more. Product: Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculo mucosal tissue. The TRANSTARTM CIRCULAR STAPLER, (STR10), 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: Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and Transtar¿ Circular Stapler Procedure Set (STR10) due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation..
- Recalling firm
- Ethicon Endo-Surgery Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-08-03
- Terminated
- 2013-07-12
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
4 on FDA's record- K051301 — PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
- K030925 — PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01
- K030411 — PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03
- K991030 — PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
K-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
Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculo mucosal tissue. The TRANSTARTM CIRCULAR STAPLER, (STR10), 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
Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and Transtar¿ Circular Stapler Procedure Set (STR10) due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.