Recall Z-0656-2020— Ethicon Endo-Surgery Inc

Name: FDA recall Z-0656-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-07

Class II · Terminated

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2019-11-07, terminated 2021-04-23. It names one FDA 510(k) clearance: K110699. Product: Ligamax 5 mm Endoscopic Multiple Clip Applier. Reason: A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Terminated
Initiated: 2019-11-07
Terminated: 2021-04-23
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K110699 — LIGAMAX 5Ethicon Endo-Sugery, LLC·cleared 2011-03-25

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

Ligamax 5 mm Endoscopic Multiple Clip Applier

Reason for recall

A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.

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