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Tektel®

TEKTEL® Surgical Steel Wire

Tektel® Surgical Stainless Steel Suture/Wire

TEKTEL Surgical stainless steel suture is a non-absorbable, sterile surgical suture composed of AISI 316L grade stainless steel conforming to ISO 5832 Part 1 “Metallic Materials for surgical implants”.

Surgical stainless steel suture meets all requirements established by the European Pharmacopoeia (E.P.) and the United States Pharmacopoeia (U.S.P.) for non-absorbable surgical sutures. Surgical stainless steel suture may also be labelled with the Brown & Sharpe Gauge (B&S) or American Wire Gauge (AWG) classifications.

USP EP B&S / AWG Gauge
5-0 1 35
4-0 1.5 34
4-0 1.5 32
3-0 2 30
2-0 3 28
0 3.5 26
1 4 25
2 5 24
3 6 23
4 6 22
5 7 20
6 8 19
7 9 18
8 10 17

INDICATIONS

Surgical stainless steel suture is indicated for use as non-absorbable suture in tissue approximation such as abdominal wound closure, hernia repair, sternal closure, and orthopedic procedures including cerclage and tendon repair. TEKTEL is for single use only.

ACTIONS

Surgical stainless steel suture elicits a minimal acute inflammatory reaction in tissue and is not absorbed.

HOW SUPPLIED

TEKTEL is available in sizes USP 5/0 through 8 (metric sizes 1-10) in a variety of pre-cut lengths with and without attached needles by permanent needle attachment or rotating techniques, in dozen boxes. TEKTEL suture is supplied sterile.

TEKTEL Sutures are available in one or two dozen boxes.

STORAGE

The product should be kept dry and clean. Keep away from direct sunlight. Do not use products after expiry (“use by”) date.

CONTRAINDICATIONS

The use of this suture is contraindicated in patients with known sensitivities or allergies to 316L stainless steel, and/or its principal metallic components metals such as chromium and nickel.

The presence of steel may interfere with certain radio diagnostics and its use is contraindicated where radio transparency of suture material is required.

WARNINGS

Users should be familiar with surgical procedures and techniques involving non-absorbable, stainless steel sutures before employing for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.

Stainless steel sutures are not to be used in direct contact with the heart, the central circulatory system or the central nervous system.

Acceptable surgical practice must be followed for the management of contaminated or infected wounds.

This device is single use. Known hazards with reuse or re-sterilization of opened/original packages of the device are cross contamination, infection, trauma.

Sterility is preserved only when opened under sterile conditions.

Do not re-sterilize.

Store at room temperature and avoid prolonged exposure to elevated temperatures.

Discard opened packages and unused sutures.

Do not use opened or damaged products.

PRECAUTIONS

In handling this or any other suture material, care should be taken to avoid damage from handling, such as kinking or excessive twisting.

As with any suture material, adequate knot security requires the accepted surgical technique of knots/twists as warranted by surgical circumstance and the experience of the surgeon.

Acceptable surgical practice should be followed to place steel sutures sufficiently distal to wound edges to reduce the incidence of the suture cutting through tissue, when the wound is placed under extreme stress.

Care should be taken to cut the knots/twists to allow for the bending of sharp ends away from surrounding tissue.

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

To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking.

Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks.

Discard used needles in "sharps" containers.

ADVERSE REACTIONS

Adverse effects associated with the use of this device include wound dehiscence, allergic response in patients with known sensitivities to 316L stainless steel, or constituent metals such as chromium and nickel infection, failure to provide adequate wound support in elderly malnourished, or debilitated patients, or osteoporosis patients, or in patients suffering from conditions which may delay wound healing, minimal acute inflammatory tissue reaction, pain and local irritation at the wound site.

Broken needles may cause complications in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of blood borne pathogens.

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