Recall Z-0672-2018— Ethicon Endo-Surgery Inc

Name: FDA recall Z-0672-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-23

Class II · Terminated

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2017-10-23, terminated 2019-07-18. It names one FDA 510(k) clearance: K983536. 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: There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Terminated
Initiated: 2017-10-23
Terminated: 2019-07-18
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K983536 — PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERSEthicon Endo-Surgery, Inc.·cleared 1998-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.