| Reason/Issue |
Global Orthopaedic has become aware that certain lots of the Global Cup Poly Liner, were manufactured with an internal diameter whose tolerance did not conform to ISO 7206-2:2011.
According to ISO 7206-2, the spherical socket of Global Cup Poly Liner, shall have an internal diameter equal to the nominal diameter within a tolerance of +0.10mm to +0.30mm. The affected lots were manufactured with an internal diameter equal to the nominal diameter within a tolerance of +0.02mm to +0.07mm. Whilst oversized relative to the nominal diameter of the femoral head, the internal diameters of the product have the potential to alter torque and/or wear rates when articulating against the femoral head, potentially leading to early mechanical loosening or loosening over time due to Osteolysis.
Post-market surveillance has not indicated any clinical or biomechanical evidence to suggest that they are associated with an increased risk of loosening, lysis or revision. |