China NMPA Product Recall - Artificial hip joint prosthesis components (trade name: Pinnacle)

The National Medical Products Administration (NMPA) of China published a report on March 17, 2017, detailing a voluntary recall initiated by DePuy Orthopaedics, Inc., a Johnson & Johnson company. The recall, reported on February 21, 2017, concerned artificial hip joint prosthesis components sold under the trade name Pinnacle. The core issue arose from a customer complaint indicating a product mix-up: a box labeled for model 121712058 was found to contain a different product, model 121714050, batch number H03632, upon opening. The specific recalled product is model 1217-12-058, batch number H03642, which points to a critical packaging or labeling error. Operating under the NMPA's regulatory framework, referencing NMPA Index No. JGXX-2017-10234 and CFDA (Imported) 2014 No. 3460154 (Revised), DePuy Orthopaedics initiated the recall. Crucially, the company confirmed that zero units of the affected product were imported into or sold within China. Consequently, no direct corrective actions were required for products in the Chinese market. However, the NMPA requested local food and drug administrations to enhance their supervision and management of similar medical devices. The recall primarily targeted international markets, including France, the UK, Australia, and Belgium, with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. serving as the responsible contact in China.