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U.S. Department of Health and Human Services

Safety

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Counterfeit Polypropylene Surgical Mesh: Initial Communication

Audience: Surgical services managers, risk managers

[UPDATED 06/08/2010] Recall classified as Class I.
[Posted 03/12/2010] Counterfeit flat sheets of polypropylene surgical mesh, used in the repair of hernias and chest wall defects, are being marketed in the United States, labeled with the C. R. Bard/Davol brand name. These products are not Bard-manufactured products. Healthcare professionals and facilities should carefully examine all manufacturers’ polypropylene surgical mesh products for their lot numbers and anything unusual that might indicate they are counterfeit. The product codes, sizes and lot numbers of the counterfeit product identified, to date, are noted in the linked Initial Communication, and recommendations/actions for healthcare professionals, healthcare facilities, and patients are provided.

Healthcare professionals and patients are encouraged to report adverse events, product problems, or suspected counterfeit product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Online: www.fda.gov/MedWatch/report.htm
  • Phone: 1-800-332-1088
  • Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
  • Fax: 1-800-FDA-0178

[06/08/2010 - Recall Notice - FDA]
[03/11/2010 - Initial Communication - FDA]