FDA-Device2018-02-28Class II

Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Ethicon Endo-Surgery Inc
Hazard

There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.

Sold states
China
Affected count
148.913
Manufactured in
4545 Creek Rd, N/A, Blue Ash, OH, United States
Products
Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0672-2018

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