China NMPA Product Recall - Hollow screws

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary recall of specific batches of hollow screws, as announced by the National Medical Products Administration (NMPA) on August 29, 2016. The recall, internally reported in June 2016, stemmed from a non-compliance issue with Chinese medical device regulations. The primary violation was the distribution of hollow screws made from pure titanium (TiCP) in China without proper registration. While the company had registered hollow screws made of titanium 6aluminum 7niobium (TiAl6Nb7), the pure titanium version, though also tested and approved by the manufacturer Synthes GmbH for implantation, lacked the necessary local registration.

Approximately 1341 units were imported into China, with 1296 units sold. Despite this regulatory lapse, Johnson & Johnson confirmed that no increased patient risk, complaints, or adverse event reports related to the recalled TiCP hollow screws had been received in China.

As required actions, affected customers were instructed to cease using the identified products immediately. Furthermore, all recalled products were to be returned to the manufacturer or destroyed locally, ensuring their removal from the market in compliance with the NMPA's regulatory oversight.