Recall Z-0533-2021— Ethicon, Inc.

Name: FDA recall Z-0533-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-23

Class II · Terminated

Class II FDA medical device recall by Ethicon, Inc., initiated 2020-10-23, terminated 2022-12-21. It names one FDA 510(k) clearance: K060713. Product: PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm. Reason: The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit..

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-10-23
Terminated: 2022-12-21
Firm location: Somerville, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K060713 — PROCEED SURGICAL MESHETHICON, Inc.·cleared 2006-05-25

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

PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm

Reason for recall

The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.

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