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Recall Observatory FDA recall evidence

Device product

Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A 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-1277-2019

April 11, 2019

Class I

Product summary

Firm
Ethicon Endo-Surgery Inc
Event
Event 82539
Status
Completed
Classification
Class I
Quantity
434,614 total
Official record key
device-enforcement:Z-1277-2019

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: February 2023 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

    reason.no_named_rule · v1.0.0

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