FDA recall Z-1275-2019

Ethicon Endo-Surgery Inc · Class I · device

Product

Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

Reason for recall

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

Distribution

Worldwide Distribution: US (nationwide) and countries of: Argentina, Aruba, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Honduras, India, Indonesia, Israel, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Malaysia, Maldives, Mexico, Nepal. Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Qatar, Saudi Arabia, Singapore, Sri Lanka, Taiwan, Thailand, UAE, Uruguay, Vietnam, and Yemen.

Key facts

Status
Completed
Initiation date
2019-04-11
Report date
2019-05-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Blue Ash, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1275-2019