China NMPA Product Recall - copolymer bone cement

The National Medical Products Administration (NMPA) issued a document on February 15, 2015, detailing a voluntary Level II recall of Copolymer Bone Cement by its manufacturer, Zimmer Inc. of the United States. Zimmer (Shanghai) Medical International Trading Co., Ltd. reported the recall to the NMPA on February 9, 2015, based on Zimmer Inc.'s own report from February 3, 2015.

The core issue leading to the recall was a failure in the product's sealing packaging. During internal quality testing, the inner packaging of specific batches (e.g., Batch Number 62849791) did not meet the required appearance inspection standards, potentially affecting product integrity. This bone cement is intended for internal fixation in total joint replacement surgery.

Under the NMPA's regulatory framework for imported medical devices, the company confirmed that the recalled product was not sold within the Chinese market; all affected inventory was returned to Zimmer Inc. As a required action, the NMPA instructed all provincial, autonomous region, and municipal food and drug administrations to enhance their supervision and management efforts concerning this product, ensuring continued vigilance over medical device safety.