Recall Z-1329-2014— Ethicon, Inc.

Name: FDA recall Z-1329-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-19

Class II · Ongoing

Class II FDA medical device recall by Ethicon, Inc., initiated 2014-02-19. It names one FDA 510(k) clearance: K060713. Product: Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.. Reason: The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination..

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2014-02-19
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, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Reason for recall

The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.

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