China NMPA Product Recall - DVR Crosslock & ePAK Plating System for Wrist Miniature Locking Plates

On February 28, 2022, the National Medical Products Administration (NMPA) issued a public notice regarding a Class III voluntary recall affecting specific medical devices. The manufacturer, Biomet Trauma, initiated this action, which was reported by Zimmer Medical (Shanghai) International Trading Co., Ltd. The recall specifically targets certain models and batches of the DVR Crosslock & ePAK Plating System, registered under Certificate No.: 20153461979. The core issue prompting this recall is the potential for insufficient sealing strength in the aseptic seals of the product packaging bags. This deficiency could compromise the sterile barrier, leading to a loss of aseptic packaging and, consequently, the sterility of the medical device. Such a breach could present a risk to patient safety if a non-sterile product is used in a medical procedure. Under the regulatory oversight of the NMPA, Biomet Trauma is undertaking a voluntary recall as the required action to address this quality concern. This measure ensures that potentially compromised products are removed from circulation. Comprehensive details, including the exact affected product specifications, batch numbers, and geographical distribution, are provided within the accompanying "Medical Device Recall Event Report Form," submitted by Biomet Trauma.