Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone

Reason: Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration

Code information: All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505

Distribution pattern: Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.