Recall Z-1268-2019— Ethicon Endo-Surgery Inc

Name: FDA recall Z-1268-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-11

Class I · Completed

Class I FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2019-04-11. It names one FDA 510(k) clearance: K983536. Product: Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.. Reason: The staplers may have an insufficient firing stroke to break the washer and completely form staples..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class I
Status: Completed
Initiated: 2019-04-11
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

Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

Reason for recall

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

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