Do not resterilize. Discard opened, unused STRATAFIX Spiral PDO and associated surgical needles. Users should be familiar with surgical procedure and techniques involving absorbable sutures before employing STRATAFIX Spiral PDO Device for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Physicians should consider the in vivo performance (under ACTIONS section) when selecting a suture for use in patients. The use of this suture may be inappropriate in elderly, malnourished or debilitated patients, or in patients suffering from conditions which may delay wound healing. The safety and effectiveness of STRATAFIX Spiral PDO has been estblished for use in fascial closures (including abdominal wall, thoracic and extremity fascial closures), gastrointestinal surgery or for use in microsurgery, therefore this product should not be used for these purposes. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts may result in calculus formation. As an absorbable suture, STRATAFIX Spiral PDO Device may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds. As this is an absorbable suture material, the use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of the sites which may undergo expansion, stretching or distention or which may require additional support. For complete product details, please see Instructions for Use.