Description
INDICATIONS
The Biomet EBI Bone Healing System is indicated for the treatment of fracture nonunions, failed fusions, and congenital pseudarthrosis in the appendicular system. A nonunion is considered to be established when there are no visibly progressive signs of healing – P790002/S028.
USAGE
The recommended daily treatment dosage is normally 10 hours per day. The maximum recommended therapeutic treatment period is nine months (approximately 270 days). This device system is a durable therapeutic electrical device intended for single patient use only under a prescription. Federal Law (U.S.A.) restricts this device to sale by or order from 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. Use of the Biomet EBI Bone Healing System on pregnant patients has not been evaluated; therefore, it is not recommended in these cases. MR unsafe – Not for MRI Use.
For complete prescribing information including contraindications, warnings, and precautions, please refer to the Biomet EBI Bone Healing System Physician Manual and Package Insert or Patient Manual PN1068220-00 or PN1068243-00.
FINANCIAL DISCLAIMER
In support of their research for or preparation of this work, one or more of the authors may have received remuneration from Zimmer Biomet.
This is an insurance-only item. As a result, any attempted purchase of this item will be automatically canceled.
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