• The safety and effectiveness of POLYDIOXANONE sutures have not been established in neural tissue, adult cardiovascular tissue, or for use in microsurgery.

• Under certain circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon.

• Do not re-sterilize.

• Do not reuse. The reuse of single-use devices can cause cross contamination and affect the device safety, performance and effectiveness, exposing patients and staff to unnecessary risk. The design and material used are not compatible with conventional cleaning and sterilization procedures.

PRECAUTIONS

• The POLYDIOXANONE suture knots must be properly placed to be secure.

• As with other synthetic sutures, knot security requires the standard surgical technique of flat and square ties with additional throws if indicated by surgical circumstance and the experience of the operator.

• As with any suture, care should be taken to avoid damage when handling.

• Avoid the crushing or crimping application of surgical instruments, such

as needle holders and forceps, to the strand except when grasping the free end of the suture during an instrument tie.

• Conjunctiva and vaginal mucosal sutures remaining in place for extended periods may be associated with localized irritation and should be removed as indicated.

• Sub-cuticular sutures should be placed as deeply as possible in order to minimize the erythema and indurations normally associated with absorption.

• Acceptable surgical practice should be followed with respect to drainage and closure of infected wounds.

ADVERSE REACTIONS

Due to prolonged suture absorption, some irritation and bleeding has been observed in conjunctiva and mild irritation has been observed in the vaginal mucosa.

• The safety and effectiveness of POLYDIOXANONE sutures have not been established in neural tissue, adult cardiovascular tissue, or for use in microsurgery.

• Under certain circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon.

• Do not re-sterilize.

• Do not reuse. The reuse of single-use devices can cause cross contamination and affect the device safety, performance and effectiveness, exposing patients and staff to unnecessary risk. The design and material used are not compatible with conventional cleaning and sterilization procedures.

PRECAUTIONS

• The POLYDIOXANONE suture knots must be properly placed to be secure.

• As with other synthetic sutures, knot security requires the standard surgical technique of flat and square ties with additional throws if indicated by surgical circumstance and the experience of the operator.

• As with any suture, care should be taken to avoid damage when handling.

• Avoid the crushing or crimping application of surgical instruments, such

as needle holders and forceps, to the strand except when grasping the free end of the suture during an instrument tie.

• Conjunctiva and vaginal mucosal sutures remaining in place for extended periods may be associated with localized irritation and should be removed as indicated.

• Sub-cuticular sutures should be placed as deeply as possible in order to minimize the erythema and indurations normally associated with absorption.

• Acceptable surgical practice should be followed with respect to drainage and closure of infected wounds.

ADVERSE REACTIONS

Due to prolonged suture absorption, some irritation and bleeding has been observed in conjunctiva and mild irritation has been observed in the vaginal mucosa.