China NMPA Product Recall - Artificial hip joint prosthesis components (trade name: Pinnacle)
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DePuy Orthopaedics, Inc., a manufacturer of artificial hip joint prosthesis components, initiated a voluntary recall of its Pinnacle product (model 121712058, batch H03642) on February 21, 2017. This action was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall was prompted by a customer complaint detailing a packaging discrepancy where a box labeled for the Pinnacle product contained a different model (121711050), indicating a potential product mix-up or mispackaging. This recall was managed under the oversight of the National Medical Products Administration (NMPA) and aligns with regulatory standards, referencing the CFDA (Imported) registration. It is important to note that the affected products were reportedly not imported or sold within China, meaning no specific corrective actions were mandated for the Chinese market. However, local food and drug administrations were advised to enhance their supervision of similar medical devices. The recall primarily impacted regions including France, the UK, Australia, and Belgium.
- Company
- DePuy Orthopaedics, Inc.
ID · 80e07165-0085-4056-aa69-de9b322de5b5