China NMPA Product Recall - shoulder joint system

Zimmer Medical (Shanghai) International Trading Co., Ltd. reported a voluntary Class II recall initiated by the manufacturer, Biomet Orthopedics, regarding their Shoulder Joint System. The recall, documented by the National Medical Products Administration (NMPA) under Index No. JGXX-2020-10113 and published on February 28, 2020, addresses complaints of incorrect size markings on specific product models and batches.The main issue identified is a significant labeling error where the size indicated on the product does not match the actual specifications. This inaccuracy could pose potential risks if the incorrect-sized implant is used in a surgical procedure. As this is a voluntary action, no specific inspection dates were provided; the recall was proactively initiated by the manufacturer in response to reported issues.Operating under the regulatory framework of the NMPA, Biomet Orthopedics is required to execute this Class II recall effectively. This involves identifying and retrieving all affected products from the market, ensuring proper communication to distributors and healthcare facilities, and managing the disposition of the non-conforming Shoulder Joint Systems to mitigate any potential patient harm. Further comprehensive details on the affected models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form".