PKGI-70-H Effective 03-2019
SURGICAL INSTRUMENT PRECAUTIONS:
Single use
surgical instruments shall never be reused. Previous stresses
may have created imperfections, which can lead to a device
failure. Protect instruments against scratching and nicking, such
stress concentrations can lead to failure.
ADVERSE EFFECTS:
Possible adverse effects are pain,
discomfort, or abnormal sensations and nerve or soft tissue
damage due to the presence of an implant or due to surgical
trauma. Fracture of the implant may occur due to excessive
activity, prolonged loading upon the device, incomplete healing, or
excessive force exerted on the implant during insertion. Implant
migration and/or loosening may occur. Metal sensitivity,
histological, allergic or adverse foreign body reaction resulting
from implantation of a foreign material may occur. Nerve or soft
tissue damage, necrosis of bone or bone resorption, necrosis of
the tissue or inadequate healing may result from the presence of
an implant or due to surgical trauma.
CLEANING:
This product is provided sterile, and should not be re-cleaned.
STERILITY:
This product is only provided sterile.
Sterile Product:
Sterile product was exposed to a minimum
dose of 25.0-kGy gamma irradiation. Acumed does not
recommend resterilization of sterile-packaged product. If sterile
packaging is damaged, the incident must be reported to Acumed.
The product must not be used, and must be returned to Acumed.
English – US / PAGE 5
US
Summary of Contents for ACU-LOC Series
Page 20: ...PKGI 70 H Effective 03 2019 Acu Loc 2 ACUMED ASTM F136 EL PAGE 20 EL...
Page 21: ...PKGI 70 H Effective 03 2019 Acumed acumed net MRI MRI 1 EL PAGE 21 EL...
Page 23: ...PKGI 70 H Effective 03 2019 25 0 kGy Acumed Acumed Acumed EL PAGE 23 EL...
