China NMPA Product Recall - Locking metal plate system

Biomet Trauma, a medical device manufacturer, initiated a voluntary Class II recall of its locking metal bone plate system. This action was reported by Zimmer Medical (Shanghai) International Trading Co., Ltd. on November 23, 2017, following a recall event report dated November 22, 2017. The core issue stemmed from the use of incorrect F.A.S.T. indicator colors during the product's manufacturing. This defect could lead to significant challenges for medical professionals in accurately identifying the correct drill bit size and drilling direction during surgical procedures, posing potential risks to patient safety and surgical efficacy. The recall is being managed under the regulatory oversight of the National Medical Products Administration (NMPA) in China. The primary required action involves the prompt voluntary removal of the affected locking metal bone plate systems from circulation. Comprehensive details, including specific product models, specifications, and batch numbers impacted by this recall, are documented in the associated Medical Device Recall Event Report Form.