FDA recall Z-0672-2018

Product

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.

Distribution

China

Key facts

Status

Terminated

Initiation date

2017-10-23

Report date

2018-02-28

Termination date

2019-07-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Blue Ash, OH, United States

Primary source

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