China NMPA Product Recall - EXTER System hip prosthesis

Howmedica Osteonics Corp., through its reporter Stryker (Beijing) Medical Devices Co., Ltd., has initiated a voluntary Class II recall of its EXTER Total Hip System (National Medical Device Registration Certificate No. 20173460477). This significant action, reported on February 28, 2022, was prompted by identified labeling confusion concerning specific models and batches of the product. While the document does not detail specific inspection dates, the recall is a proactive measure taken by the manufacturer. The regulatory oversight for this recall falls under the National Medical Products Administration (NMPA), the governmental body hosting this official notice. As a required action, Howmedica Osteonics Corp. is actively withdrawing the affected units from distribution. Further detailed information, including precise affected product models, specifications, and batch numbers, is accessible within the 'Medical Device Recall Event Report Form' attachment, which is crucial for identifying and managing the recalled devices effectively.