Contraindications - Johnson & Johnson DePuy Mitek HEALIX PEEK Mode D'emploi

INDICATIONS
The HEALIX Dual Threaded Suture Anchor is intended
for:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP
Lesion Repair, Biceps Tenodesis, Acromio-Clavicular
Separation Repair, Deltoid Repair, Capsular Shift or
Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization,
Achilles Tendon Repair.
Knee: Medial Collateral Ligament Repair, Lateral
Collateral Ligament Repair, Posterior Oblique Ligament
Repair, Iliotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial
Collateral Ligament Reconstruction.
Hip: Capsular repair, acetabular labral repair.

CONTRAINDICATIONS

1. Procedures other than those listed in the
INDICATIONS section.
2. Pathologic conditions of bone such as cystic changes
or severe osteopenia that would impair its ability to
securely fix the HEALIX PEEK anchor.
3. Pathologic changes in the soft tissues being fixated
to bone that would prevent their secure fixation by the
HEALIX PEEK anchor.
4. Comminuted bone surface that would militate against
secure fixation of the HEALIX PEEK anchor.
5. Physical conditions that would eliminate or tend to
eliminate adequate implant support or retard healing,
i.e., blood supply limitation, previous infection, etc.
6. Conditions which tend to limit the patient's ability to
restrict activities or follow directions during the healing
period.
7. The HEALIX PEEK anchor is not designed for and
should never be used to attach artificial ligaments.
PRECAUTIONS
1. The HEALIX PEEK anchor is supplied STERILE, and
is intended for single use only. Do not resterilize. Do
not use if sterile packaging appears to be damaged.
2. Discard if open but unused. Do not use after
expiration date.
3. Inspect all instruments for damage before use. Do not
attempt to repair.
4. A surgeon should not begin clinical use of the
HEALIX PEEK anchor without reviewing the
Instructions for Use and practicing the procedure in a
skills laboratory.
5. Inserting the awl less than the specified depth,
axial misalignment or levering with the anchor upon
insertion, may result in anchor fracture.
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