The fixation loop of the STRATAFIX Spiral PDS Plus Device should be deployed by users familiar with surgical procedures, techniques and tissues and the use of absorbable devices before employing the STRATAFIX Spiral PDS Plus Device for wound closure, as risk of wound separation may vary with the site of application and the suture material used. Physicians should consider the quantity and quality of tissue in which the loop will be anchored. The use of this device may be inappropriate in highly vascularized tissue or fragile tissue that cannot withstand potential further tigthening/constriction within the loop. Physicians should consider the in vivo performance (under ACTIONS section) when selecting a device for use in patients. The use of this device may be inappropriate in elderly, malnourished or debilitated patients, or in patients suffering from conditions which may delay wound healing. As with any foreign body, prolonged contact of any device with salt solutions, such as those found in the urinary or biliary tracts may result in calculus formation. As an absorbable device, PDS Plus 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 device 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. The safety and effectiveness of the STRATAFIX Spiral PDS Plus Device have not been established for use in fascial closures (including abdominal wall, thoracic and extremity fascial closures), gastrointestinal anastomoses, cardiovascular tissue, neural tissue, osseous tissue, tendinous tissue, ophthalmic surgery or for use in microsurgery. Do not resterilize/reuse. Reuse of this device (or portions of this device) may create a risk of product degradation, which may result in device failure and/or contamination, which may lead to infection or transmission of blood-borne pathogens to patients and users. Discard open packages and unused devices. Discard packaging that is damaged or opened. Do not use after expiration date.