Orthofix NGage Gebrauchsanleitung Seite 3

Packaging:
Packages for each of the components should be intact upon receipt. If a consignment system
is used, all sets should be carefully checked for completeness and all components should be
carefully checked for damage prior to use. Damaged packages or products should not be used
and should be returned to Orthofix.
The NGage Surgical Mesh System instruments and implants are provided in modular cases
specifically intended to contain and organize the system's components. The system's instruments
are organized into trays within each modular case for easy retrieval during surgery. These trays
also provide protection to the system components during shipping. Additionally, individual
instruments and implants are provided in sealed poly bags with individual product labels.
Product Complaints:
Any Healthcare Professional (e.g., customer or user of this system of products) who has any
complaints or who has experienced any dissatisfaction with the product quality, identity,
durability, reliability, safety, effectiveness and/or performance, should notify Orthofix Inc., 3451
Plano Parkway, Lewisville, TX 75056, USA, by telephone at 1-214-937-3199 or 1-888-298-5700
or by e-mail at complaints@orthofix.com.
Further Information:
A recommended operative technique for the use of this system is available upon request from
Orthofix at the phone numbers provided above.
Latex Information:
The implants, instruments and/or packaging material for the NGage Surgical Mesh System are
not formulated with and do not contain natural rubber. The term "natural rubber" includes
natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains
natural rubber in its formulation.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
AW-74-9902 Rev.AC
NG-1701-PL-US © Orthofix, Inc. 5/2017
CAPA Symbols Chart revised2 - NGage
3
Federal (U.S.A.) law restricts this device to sale
by or on the order of a physician
See Instructions for Use
Manufacturer
Authorized
Orthofix.com/IFU
Representative
Single Use Only
Lot Number
Do Not Reuse
Catalogue Number
Provided Non-Sterile