Medical device recalls Moderate risk

Ethicon Endo-Surgery Inc recalls Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to…

Recall date
October 23, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0672-2018
FDA classification
Class II
Brand / firm
Ethicon Endo-Surgery Inc
Sold / distributed
China

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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