Orthofix AGILE NAIL Gebrauchsanweisung Seite 6

RISKS DUE TO THE RE-USE OF "SINGLE USE" DEVICE
IMPLANTABLE DEVICE*
The "SINGLE USE" implantable device* of Orthofix is identified through symbol " " reported on the product label.
After the removal from the patient, the implantable device* has to be discarded.
The re-use of implantable device* introduces contamination risks for users and patients.
The re-use of implantable device* can not guarantee the original mechanical and functional performances, compromising the effectiveness of the products and introducing health risks for the patients.
(*): Implantable device
Any device intended to be totally/partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is considered an implantable device.
NON IMPLANTABLE DEVICE
The "SINGLE USE" non implantable device of Orthofix is identified through symbol " " reported on the label or indicated in the "Instructions For Use" supplied with the products. The re-use of "SINGLE USE"
non implantable device cannot guarantee the original mechanical and functional performances, compromising the effectiveness of the products and introducing health risks for the patients.
CAUTION
Federal Law (USA) restricts this device to sale by or on the order of a physician.
Manufacturer contact
Please contact your local Orthofix sales representative for further details.
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