Pyng Medical Corp.

Pyng Medical Corp.

November 16, 2010 10:25 ET

Pyng Medical Initiates Voluntary Recall of the FASTx™

VANCOUVER, BRITISH COLUMBIA--(Marketwire - Nov. 16, 2010) - Pyng Medical (TSX VENTURE:PYT) announced today that it has initiated a voluntary recall of the FASTx™ Sternal Intraosseous Device. Pyng received feedback regarding inconsistent performance of FASTx™ in several early training sessions that were conducted and, as a result, recalled the first 400 devices shipped to distributors. Pyng has discontinued shipment of future devices until it can evaluate these happenings and determine root cause.

"This voluntary recall was initiated because it is simply the right thing to do when there is any question regarding the performance of a medical device," said Mark Hodge, President and CEO of Pyng, in a statement related to the company's action. "The Pyng technical team is working rapidly to analyze these events and determine a course of action. We will ensure that the FASTx™ Sternal Intraosseous Device is performing as we expect it to perform and will provide ongoing updates."

The revolutionary clinical benefits available through utilization of the FAST1® Sternal Intraosseous Device will not be impacted by this voluntary action. During this period of FASTx™ evaluation, the FAST1® continues to ship to customers desiring the benefits of sternal IO, anatomical land marking, automatic depth control, and secure placement.

About Pyng Medical Corp.

Pyng Medical Corp. commercializes award-winning trauma and resuscitation products for front-line critical care personnel. Pyng's expanded product portfolio includes a variety of innovative, lifesaving tools. With growing markets in North America, Europe and Asia, Pyng offers user-preferred medical devices for use by hospital staff, emergency medical services and military forces worldwide.

Safe Harbour Statement; Forward-Looking Statements: This release may contain forward-looking statements based on management's expectations, estimates and projections. All statements that address expectations or projections about the future, including statements about the Company's strategy for growth, product development, market position, expected expenditures and financial results are forward-looking statements. Some of the forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "projects", "indicates", and similar expressions. These statements are not guarantees of future performance and involve a number of risks, uncertainties and assumptions. Many factors, including those discussed more fully elsewhere in this release and in documents which may be filed with the British Columbia Securities Commission, the Alberta Securities Commission, the Ontario Securities Commission, the TSX Venture Exchange, as well as other USA Commissions, could cause results to differ materially from those stated. These factors include, but are not limited to changes in the laws, regulations, policies and economic conditions, including inflation, interest and foreign currency exchange rates, of countries in which the Company does business; competitive pressures; successful integration of structural changes, including restructuring plans, acquisitions, divestitures and alliances; cost of raw material, research and development of new products, including regulatory approval and market acceptance; and seasonality of sales in some products.

Neither the TSX Venture Exchange nor its Regulatory Service Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information

  • Pyng Medical Corp.
    Mark F. Hodge
    Chief Executive Officer
    1-800-349-7964 (x208)