China NMPA Product Recall - Shoulder joint system accessory kit (product name: Anatomical)

Zimmer GmbH, a medical device manufacturer, initiated a voluntary Class II recall for its Shoulder Joint System Accessory Kit, known by the trade name Anatomical. This action was officially reported by Zimmer (Shanghai) Medical International Trading Co., Ltd. on March 9, 2020. The primary reason for the recall was the identification of a manufacturing discrepancy: a color error found in the AS humeral polyethylene 40mm 0° trial mold, which impacted specific models and batches of the accessory kit. The recall is being conducted under the regulatory oversight of the National Medical Products Administration (NMPA) in China, where the product holds registration certificate number CFDA (Imported) 2013 No. 1103138. A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Zimmer GmbH’s immediate and voluntary recall demonstrates a commitment to maintaining product quality and ensuring patient safety by addressing potential issues proactively. Comprehensive details about the affected product models, specifications, and batch numbers are available in the accompanying "Medical Parts Report Form" and "Medical Device Recall Event Report Form" published by the NMPA. This action aligns with established regulatory protocols to safeguard public health.