Device product
Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A 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.
Z-1269-2019
Product summary
- Event
- Event 82539
- Status
- Completed
- Classification
- Class I
- Quantity
- 434,614 total
- Official record key
device-enforcement:Z-1269-2019
Official wording
Reason: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Code information: All Lots within EXPIRATION Date Range: December 2022 March 2024
Distribution pattern: 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.
Derived failure modes
-
Unknown
The staplers may have an insufficient firing stroke to break the washer and completely form staples.