Product information on the Biomet® EBI® Bone
INDICATIONS: The Biomet® EBI Bone Healing
System® is indicated for the treatment of fracture
nonunions, failed fusions, and congenital pseudarthrosis in the
appendicular system – (P790002/S028).
USAGE: Federal Law (U.S.A.) restricts these devices to sale by
or on the order of a physician. Rx Only - Prescription Only - Single
Patient Use Only - Not for Re-Sale or Re-Distribution - Do Not Reuse.
CONTRAINDICATIONS: Nonunion fractures in which a synovial
pseudarthrosis (fluid filled gap) exists.
Under certain conditions, electromagnetic stimulation could inhibit
or impair the functioning of certain external, non-invasive and/or
implanted, invasive active medical devices inclusive of “all active
electrical and non-active conductive/metallic implants”. Use of the
Biomet® EBI Bone Healing System on pregnant patients has
not been evaluated; therefore, it is not recommended. MRI scans should
not be performed on patients until the device system has been
WARNINGS: Use of the Biomet® EBI Bone Healing System
for the spine and skull have not been evaluated.
PRECAUTIONS: Nonunion fractures with gaps in excess of 1.0 cm
or the presence of fixation devices or instrumentation made from
magnetic materials may compromise a successful treatment outcome.
Complete prescribing information including contraindications,
warnings and precautions associated with the use of this device may be
found online at www.LearnAboutBoneHealing.com
or by contacting customer service at 1-800-526-2579, extension 6000.
If you have additional questions regarding your doctor’s
instructions in using this device, or you are experiencing any type of
reaction with the use of this device, contact your doctor immediately.
For further product information, including warnings, refer to the
Patient Manual at www.LearnAboutBoneHealing.com,
or contact Customer Service at 1-800-526-2579, extension 6000.