China NMPA Product Recall - Artificial hip joint prosthesis - femoral head

Serf (France) has initiated a voluntary Class III recall of its artificial hip joint prosthesis - femoral head. This action, published by the National Medical Products Administration (NMPA) on January 24, 2019, addresses critical product discrepancies. The recall stems from identified inconsistencies where important dimensions of the affected medical device failed to meet specified technical requirements. Under the oversight of the NMPA, Serf (France) is taking corrective measures to withdraw the non-compliant products from the market. A Class III recall indicates that while the use of the product is unlikely to cause adverse health consequences, it still violates regulatory standards. Detailed information regarding the specific models, specifications, and batch numbers of the impacted artificial hip joint prostheses can be found in the "Medical Device Recall Event Report Form" attachment referenced in the NMPA's announcement. This proactive recall highlights the manufacturer's commitment, guided by the NMPA's regulatory framework, to ensure product safety and adherence to technical specifications in the medical device sector.