China NMPA Product Recall - Arcos Modular Revision System (Femoral Stem and Accessories)

Biomet Orthopedics, via Zimmer Medical (Shanghai) International Trading Co., Ltd., has initiated a voluntary recall of specific models and batches of its Arcos Modular Revision System (Revision Femoral Stem and Accessories). This action, announced by the National Medical Products Administration (NMPA) on June 22, 2021, addresses a manufacturing flaw where a mismatch in the boring bar during production resulted in a "chatter mark" on the inner conical surface of the product. This defect has the potential to compromise the device's performance and patient safety. Under the regulatory framework of the NMPA, Biomet Orthopedics is undertaking this recall to retrieve the affected medical devices. Detailed information, including specific registration certificate numbers (e.g., 20163461304, 20163131304) and batch numbers, is provided in a Medical Device Recall Event Report Form. This proactive measure ensures the manufacturer's compliance with quality standards and aims to mitigate potential risks associated with the identified product integrity issue.