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January 22, 2018To:Surgeons/ HospitalsSubject:URGENT FIELD SAFETY NOTICE CORRECTION UPDATEReference:MFA 2017425 (Update)Affected Products: Bone Cement and Optical Product Name OPTICAL 40 REFRAIN REVISION OPTICAL
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How to fill out bone cement product and

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How to fill out bone cement product and

01
Prepare all the necessary materials including bone cement powder and liquid.
02
Mix the powder and liquid together according to the manufacturer's instructions.
03
Use a syringe or a cement gun to fill the bone defect with the mixed cement.
04
Press the cement firmly to ensure good bonding with the surrounding bone.
05
Allow the cement to set and harden before continuing with any further procedures.

Who needs bone cement product and?

01
Patients undergoing joint replacement surgeries
02
Patients with fractures that require stabilizing implants
03
Individuals with bone tumors that need to be treated
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Bone cement product is a material used in orthopedic surgeries to secure implants to bones.
Manufacturers and distributors of bone cement products are required to file the necessary documentation.
The required information can be filled out electronically through the designated regulatory agency's online platform.
The purpose of bone cement product is to provide stability and support for orthopedic implants during surgery.
Information such as ingredients, manufacturing process, and intended use must be reported for bone cement products.
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