PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: February 28, 2018 Initiated: October 23, 2017 #Z-0672-2018

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Ethicon Endo-Surgery Inc
Units Affected
148.913
Distribution
China
Location
Blue Ash, OH

Frequently Asked Questions

What product 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.. Recalled by Ethicon Endo-Surgery Inc. Units affected: 148.913.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 28, 2018. Severity: Moderate. Recall number: Z-0672-2018.