Recall Z-0819-2014— Davol, Inc., Subs. C. R. Bard, Inc.

Name: FDA recall Z-0819-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-03

Class II · Terminated

Class II FDA medical device recall by Davol, Inc., Subs. C. R. Bard, Inc., initiated 2014-01-03, terminated 2015-12-23. It names one FDA 510(k) clearance: K102766. Product: Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.. Reason: Product labeling does not match product configuration..

Recalling firm: Davol, Inc., Subs. C. R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-01-03
Terminated: 2015-12-23
Firm location: Warwick, RI, United States

510(k) clearances named in this recall

1 on FDA's record

K102766 — COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEMC.R. Bard, Inc.·cleared 2010-12-16

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

Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.

Reason for recall

Product labeling does not match product configuration.

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