China NMPA Product Recall - Hip prosthesis - ceramic femoral head and liner
Discuss this record with AI
The National Medical Products Administration (NMPA) announced on June 19, 2024, a voluntary Class III recall initiated by Zimmer GmbH, based in Switzerland. This recall pertains to specific hip prostheses, notably ceramic femoral heads and liners, identified by model number 20143135650. The primary issue prompting this action is the discovery of mixed batches involving different models of these devices. Zimmer (Shanghai) Medical International Trading Co., Ltd. reported the recall. Crucially, while Zimmer GmbH is taking this measure to address the product discrepancy, it has been confirmed that the specific batches of recalled products were not imported into China. Detailed information regarding the models, specifications, and affected batches is documented in the "Medical Device Recall Event Report Form" provided by Zimmer Medical (Shanghai) International Medical Trading Co., Ltd. This proactive step by Zimmer GmbH underscores the company's dedication to maintaining product safety and adhering to regulatory standards, effectively managing potential quality control challenges related to batch segregation to mitigate any risks to patients. The NMPA's public notification ensures transparency regarding this global product safety initiative.
- Company
- Zimmer GmbH
ID · 0cb8d9ee-1694-4ad9-a250-3580e6b2cc8b