Johnson & Johnson DePuy Mitek SPIRALOK, Manual

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4
4. Do not use where pre-healing suture tension will
exceed 20 lbs. for size #2 suture, as suture may fail.
5. This device is not approved for screw attachment or
fixation to the posterior elements (pedicles) of the
thoracic or lumbar spine.
6. As a braided suture, which is essentially absorbed
over 1.5 to 2.5 years, the PANACRYL suture may act
as a foreign body over an extended period of time.
The surgeon should consider whether use of an
absorbable suture is appropriate in specific situations
such as in wounds that carry an increased risk of
infection or contamination.
7. Users should be familiar with surgical procedures and
techniques involving absorbable and non-absorbable
suture before employing ORTHOCORD suture for
wound closure, as risk of wound dehiscence may
vary with the site of application and the suture
material used.
PRECAUTIONS
A surgeon should not begin clinical use of a DePuy Mitek
anchor without reviewing the instructions for use and
practicing the procedure in a skills laboratory.
Inspect all instruments for damage before use. Do not
attempt to repair.
ADVERSE EFFECTS
Adverse effects of absorbable implanted devices include
mild inflammatory and foreign body reactions.
STERILIZATION
The SPIRALOK suture anchor is provided sterile.
Do
not resterilize.
A DEPUy MITEK ANCHOR MUST NEVER BE
REUSED.
STORAGE
Store in a cool dry place below 26°C (80°F), away from
moisture and direct heat. Discard if open but unused. Do
not use after expiration date.
*Data on File
ESPAÑOL
Anclaje de sutura roscado absorbible
SPIRALOK™
DESCRIPCIÓN
El anclaje SPIRALOK es un anclaje de sutura roscado
de ácido poliláctico (APL) previamente cargado sobre
un conjunto insertador desechable para la fijación
de dos hilos de sutura calibre 2 al hueso. La sutura
trenzada no absorbible ETHIBOND
® , la sutura trenzada