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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a surgical device defect that may result in incomplete staple formation, posing a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
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 resectio
- Manufacturer
- Ethicon Endo-Surgery Inc
- 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
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