Agency classClass IOur severity:Severe FDA (Devices)·Z-0057-2013·Announced 2012-10-24

Ethicon Recalls Hemorrhoidal Circular Staplers Due to Firing Defect

Ethicon Endo-Surgery is recalling specific lots of PROXIMATE PPH and Transtar circular staplers because a firing defect may cause incomplete staple formation.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

Ethicon Endo-Surgery Inc is voluntarily recalling specific production lots of PROXIMATE PPH Hemorrhoidal Circular Staplers (models PPH01 and PPH03) and Transtar Circular Stapler Procedure Sets (model STR10). The recall covers 157,881 devices distributed worldwide, including nationwide distribution in the United States and various international markets.

The recall was initiated due to a difficulty in firing the device, which may result in an incomplete firing stroke and subsequent incomplete staple formation. This defect affects the surgical treatment of anorectal wall defects by means of transanal stapling and resection.

Healthcare providers and facilities that have received these devices should stop using them and contact Ethicon Endo-Surgery for instructions on return or replacement. Consumers should not use these surgical devices, as they are intended for professional medical use.

The recalled product

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…
Manufacturer: Ethicon Endo-Surgery Inc
Category: Medical Device — Surgical Instruments
Hazard: device-malfunction
surgical-complication
Affected units: 157,881

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

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

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Same manufacturer · Ethicon Endo-Surgery Inc

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