China NMPA Product Recall - Disposable drill bits
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Medtronic Xomed, Inc. initiated a voluntary Class III recall of its single-use drill bits, a measure officially reported by Medtronic (Shanghai) Management Co., Ltd. to the National Medical Products Administration (NMPA) on August 23, 2024. This critical action was prompted by the inadvertent shipment of an expired product to a facility in Canada. The affected medical devices, identified under National Medical Device Registration Certificate No. 20162044471, necessitated a prompt response from the manufacturer to uphold product safety standards. While the global manufacturer, Medtronic Xomed, Inc., conducted this recall to address the specific issue of outdated inventory entering the supply chain, it is important to clarify that the particular products involved in this recall were not distributed or imported into the Chinese market. The company's proactive stance underscores the importance of stringent inventory management and distribution controls to prevent potential risks associated with the use of expired medical equipment. The NMPA's publication of this information reflects the broader regulatory transparency concerning medical device safety, even when incidents occur in international markets. This ensures public awareness and reinforces adherence to quality management systems across the industry.
- Company
- Medtronic, Inc. (USA)
ID · 5155d47b-c1e2-4062-8c14-9a62d5560043