China NMPA Product Recall - Metal bone needles

Smith & Nephew, Inc. has initiated a voluntary Class II recall of specific metal bone needles, identified by item number 20153131140, due to critical issues related to incorrect product packaging. This recall was formally reported by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. on July 16, 2024, operating under the regulatory framework of the National Medical Products Administration (NMPA).

The core issue involves packaging discrepancies that could potentially compromise the sterility, integrity, or intended use of the medical devices. Despite the global nature of the manufacturing entity, the specific batches of affected products were not imported or distributed within China. As a required action, the manufacturer is proactively retrieving these devices from the market to prevent any potential risks to patient safety or product efficacy that might arise from the packaging error.

Further comprehensive details, including the specific models, precise specifications, and all involved batch numbers, are documented in the official "Medical Device Recall Event Report Form." This voluntary recall highlights Smith & Nephew's commitment to upholding rigorous product quality standards and ensuring adherence to international medical device regulations, thereby safeguarding public health by effectively addressing and mitigating potential product-related concerns.