Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A 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.
Reported: May 22, 2019 Initiated: April 11, 2019 #Z-1274-2019
Product Description
Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A 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.
Details
- Recalling Firm
- Ethicon Endo-Surgery Inc
- Units Affected
- 434,614 total
- 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.
- Location
- Blue Ash, OH
Frequently Asked Questions
What product was recalled? ▼
Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A 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.. Recalled by Ethicon Endo-Surgery Inc. Units affected: 434,614 total.
Why was this product recalled? ▼
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2019. Severity: Critical. Recall number: Z-1274-2019.
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