GraMedica Alerts Products from Unauthorized Sources Could Result in Serious Harm to Patients

MACOMB, Mich. - Sept. 8, 2015 - PRLog -- GraMedica has been made aware of foreign or unlicensed sources and suppliers attempting to sell its products. These products may be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe under proper conditions as required by U.S. and other Foreign Government law, regulations, and standards. Such products may be contaminated and put patients at risk of infections and exposure to dangerous products.

GraMedica is very concerned that products distributed by these sources may cause harm to patients. Included in these sellers representation of GraMedica’s products are contrary to CAUTIONS in the Instructions for Use of the HyProCure® Sinus Tarsi Implant/Stent:

•  Federal law (US) restricts this device to sale, distribution and use by or on the order of a physician.

•  This implant is provided sterile for single use only. The package should be inspected for damage, if there is a question of sterility, another implant should be used.

•  The expiration date should be checked; if expired the implant should not be used. If the implant appears defective, it should not be used.

•  This implant should NOT be re-sterilized or reused. Reuse or re-sterilization may result in inadequate cleaning / sterilization of device, which could result in patient infection.

•  The implants should be stored in their protected sterilized packages until use. Use relevant sterile technique when removing the implant from the packaging. Inspect the implant for any physical defects and return any implant(s) that exhibit surface or configuration damage.

Products sold by these sellers, including the HyProCure® Sinus Tarsi Implant Instrument Set, should be considered to be mislabeled, resulting in adulterated or misbranded products. Sellers and purchasers of these products may be in violation of 21 U.S.C. § 331(a) 333(a)(2) – Prohibited Acts and the Federal Food, Drug, and Cosmetic Act, and is illegal. Foreign or unlicensed sources and suppliers attempting to sell GraMedica products are falsely representing and without proper authority.

Physicians with questions should contact GraMedica at +1 586 677 9600 or email info@gramedica.com.

About GraMedica®

GraMedica is a global orthopedic medical device company passionate about creating innovative foot and ankle products that improve patient options and outcomes. Together with our sister organization, the Graham International Implant Institute (GIII), we educate foot and ankle surgeons in over 50 countries. We are committed to helping create ongoing improvement in the quality of healthcare for both patients and physicians through premier product lines including the HyProCure® Sinus Tarsi System and osteo-WEDGE™ Bone Locking Plate System.

To learn more about GraMedica, please visit our website at http://www.gramedica.com. Physicians can learn more about Graham International Implant Institute at http://www.grahamiii.com.