CY966P

Trexon monofilament absorbable suture product and in-use images

Indications, Safety, and WarningsIndicationsTrexon™ monofilament synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological surgery.Contraindications

This suture, being absorbable, should not be used where extended approximation of tissue is required.

Warnings

This device is provided sterile for single-use only. Sterile unless packaging has been opened or damaged. Visually inspect the package before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization may compromise the structural integrity of the device or may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.

Before employing Trexon™ sutures for wound closure, healthcare professionals should consider the characteristics of the wound and absorption profile of the suture as the risk of wound dehiscence may vary with the site of application and the suture material used.

As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.

Acceptable surgical practice must be followed with respect to drainage and closure of contaminated or infected wounds.

The use of this suture may be inappropriate for patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.

The use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.

The device needle contains nickel that may cause allergic reaction.

Precautions

In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.

Adequate knot security requires the accepted surgical technique of flat, square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon.

The use of additional throws may be particularly appropriate when knotting monofilaments.

Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated.

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

Consideration should be taken in the use of absorbable sutures in tissue with poor blood supply as suture extrusion, delayed absorption, and sterile abscess may occur.

Discard open, unused sutures in accordance with end user’s sharps containment, handling, and disposal procedures.

Dispose of used sutures in accordance with the end-user’s medical and biological waste disposal requirements. “Sharps” should be disposed of in accordance with end user’s sharps containment, handling, and disposal procedures. Use caution during handling and disposal to avoid injury.

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