China NMPA Product Recall - Locking plate

The National Medical Products Administration (NMPA) published a document on February 26, 2014, concerning a recall of Locking Bone Plates (CFDA Import Medical Device No. 20113460280 (Revised)) initiated by Synthes GmbH, Switzerland. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the product's distributor, informed the NMPA on February 19, 2014, about the manufacturer's recall, which commenced on February 10, 2014.

The core issue prompting the recall was the erroneous duplication of batch number 3180479, which was mistakenly labeled as the model number. This critical mislabeling impacted product identification and traceability for 249,679 units. The affected products were distributed across several regions, including France, the UK, Sweden, South Africa, Australia, and Colombia.

While operating under the NMPA's regulatory framework, which advised provincial administrations to strengthen supervision of such products, the recall's scope specifically excluded China. Neither imported nor sold within the Chinese market, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. confirmed that no further actions, investigations, or reports would be undertaken in China beyond their initial notification to the State Food and Drug Administration. The recall's primary objective was to rectify the labeling error and maintain product integrity and patient safety in the international markets where the affected devices were distributed.