China NMPA Product Recall - Achilles tendon suture guide

General Medical Devices (Shanghai) Co., Ltd., representing manufacturer Newdeal SAS in China, has initiated a Level III voluntary recall of its Achilles Tendon Suture Guide (Model 119700, Batch F4FV). This action, reported to the National Medical Products Administration (NMPA) on September 5, 2016, addresses a potential issue with the sterile outer packaging. The company discovered that the packaging might not maintain its seal integrity throughout the product's claimed sterilization period, thereby potentially affecting the sterility of the inner packaging's outer surface.

Despite this concern, internal verification has confirmed that the medical device itself remains sterile within its inner packaging, and no adverse events or complaints have been reported regarding this issue. The recall affects 155 units globally, with 142 units sold in China. As part of the corrective actions, General Medical Devices (Shanghai) Co., Ltd. is conducting a comprehensive safety assessment of the identified risk. Additionally, all relevant distributors have been instructed to inspect their inventory and arrange for the return of any affected products. This proactive recall demonstrates the company's commitment to product safety and regulatory compliance.