Global Cup Poly Liner, Neutral prostheses(part of the Global Cup Acetabular System) 의 리콜

Recall

RC-2017-RN-01262-1

Class II

2017-11-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01262-1

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.

Global Orthopaedic is informing implanting surgeons to consider the provided information during follow up for relevant patients.