China NMPA Product Recall - Artificial hip joint prosthesis components (trade name: Pinnacle)
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DePuy Orthopaedics, Inc., a division of Johnson & Johnson Medical Companies, initiated a voluntary recall of specific Artificial Hip Joint Prosthesis Components under the brand name Pinnacle. This recall was reported to the National Medical Products Administration (NMPA) by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on February 21, 2017. The core issue stemmed from a packaging error where a customer discovered an incorrect product model (121714050, batch H03632) inside a box labeled for a different model (121712058). The affected products, registered under CFDA (Imported) No. 20143460154, were distributed in regions such as France, the UK, Australia, and Belgium. Importantly, the company confirmed that no units of the implicated product were imported into or sold within China. As a result, no specific corrective actions were necessary for the Chinese market. The NMPA subsequently directed its regional food and drug administrations to intensify oversight and management of comparable medical devices, reinforcing regulatory vigilance for product quality and safety.
- Company
- DePuy Orthopaedics, Inc.
ID · 4c063e3f-c75d-4cf0-800d-3ec35f8904e4