Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Composix L/P with Echo PS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Composix L/P with Echo PS see related information
Date Initiated by Firm January 03, 2014
Date Posted January 23, 2014
Recall Status1 Terminated 3 on December 23, 2015
Recall Number Z-0820-2014
Recall Event ID 67149
510(K)Number K102766  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product Composix L/P with Echo PS 6" X 8" Product Code 0144680

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.
Code Information Lot# HUXG0491, HUXH0295
Recalling Firm/
Manufacturer		 Davol, Inc., Subs. C. R. Bard, Inc.
100 Crossings Blvd
Warwick RI 02886-2850
For Additional Information Contact Customer Service Department
800-556-6275
Manufacturer Reason
for Recall		 Product labeling does not match product configuration.
FDA Determined
Cause 2		 Labeling Change Control
Action Davol, Inc., Subs. C. R. Bard, Inc.sent a customer notification letter on January 3, 2013, to all affected customers via Fedex to inform consignees that the Instructions for Use (IFU) and graphic contained on the inside of the product carton bottom references two features added to the inflation tube that are not present on the product they received. Please contact the Davol Customer Service Department at 1-800-556-6275 or C. R. Bards Medical Services & Support Department at 1-800-562-0027 if you have any questions. Consignees are asked to complete an effectiveness check form and return it via fax to 401-825-8753. For questions regarding this recall call 800-556-6275,
Quantity in Commerce 46
Distribution Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = C.R. BARD INC
-
-