China NMPA Product Recall - Ceramic lining

On March 10, 2015, the National Medical Products Administration (NMPA) published details of a voluntary recall initiated by B. Braun Medical (Shanghai) International Trading Co., Ltd. The recall, formally reported on January 30, 2015, concerned specific batches of Ceramic Liners manufactured by Aesculap AG. The core issue involved a critical labeling discrepancy: the outer packaging incorrectly indicated the internal product size as 32mm, while the actual ceramic liner measured 36mm. This inconsistency between inner and outer packaging labels prompted the recall of all affected products in Batch No. 52074933. While the difference in size necessitates distinct system components for use, minimizing the risk of incorrect implantation post-surgery, the company emphasized that no anticipated risk existed for patients who had already undergone surgery. This action was taken under the regulatory oversight of the NMPA to ensure medical device safety and accurate product information. B. Braun implemented a series of corrective measures: affected products were immediately locked in the ordering system, quantities imported into China were verified, and comprehensive customer notifications were issued. All identified affected products were subsequently returned to B. Braun, with documented confirmation, and ultimately sent back to the manufacturer, Aesculap AG, to address the labeling error and maintain product integrity.