# China NMPA Product Recall - Ceramic lining

Source: https://www.globalkeysolutions.net/records/china_product_recall/aesculap-ag/3fe4b0be-f8bb-4d6f-a4e7-6717135bdb02/
Source feed: China

> China NMPA product recall for Ceramic lining by Aesculap AG published March 10, 2015. Recall level: . On March 10, 2015, the National Medical Products Administration (NMPA) published details of a volunt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: B. Braun Medical (Shanghai) International Trading Co., Ltd. voluntarily recalls ceramic linings
- Company Name: Aesculap AG
- Publication Date: 2015-03-10
- Product Name: Ceramic lining
- Recall Reason: Some of the products in the affected batch had incorrect outer labels, resulting in inconsistencies between the inner and outer packaging labels. The outer label indicated an internal product size of 32mm, while the actual product size may be 36mm. Therefore, an investigation has been launched against all products in this batch. Since the two sizes (32mm and 36mm) require different system joint components for use, there was no anticipated risk for patients who have already undergone surgery.
- Discovering Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Aesculap AG
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/aesculap-ag/59485d99-dc5a-4710-8d68-32cd0df59fe2/