China NMPA Product Recall - Total Knee System - Oxinium Femoral Implant
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Smith & Nephew, Inc., USA, initiated a voluntary Class II recall of its Total Knee System - Oxinium Femoral Implant, as reported by the National Medical Products Administration (NMPA) on April 12, 2022. The recall was prompted by an error in the expiration date information printed on the product labels of specific models and batches. This issue led Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. to report the discrepancy, resulting in the manufacturer's decision to remove the affected implants from the market. The recall signifies a commitment to product safety and compliance with regulatory standards overseen by the NMPA, ensuring that medical devices meet specified quality and labeling requirements. Further details on the specific registration number, specifications, and batch numbers are documented in the "Medical Device Recall Event Report Form" associated with this action.
- Company
- Smith & Nephew Inc.
ID · f729e0f9-45b7-44b4-a5e9-e3ec925d2705