FDA Device recall Z-0057-2013
Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and…
- FDA Device
- Class I
- terminated
- Published 2012-10-24
On 2012-10-24 the FDA classified a Class I recall of Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and… by Ethicon Endo Surgery, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0057-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-08-03 |
| Published | 2012-10-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ethicon Endo Surgery |
| Distribution | US |
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.
Identifiers
| code_info | PPH01: 68 lots; 19,030 pieces; Expiration date April 2016 -June 2017; PPH03: 494 lots; 144,963 pieces; Expiration da…PPH01: 68 lots; 19,030 pieces; Expiration date April 2016 -June 2017; PPH03: 494 lots; 144,963 pieces; Expiration date March 2016 - June 2017; STR10: 3 lots; 432 pieces; Expiration date Sept 2016 - Oct 2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0057-2013%22
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