China NMPA Product Recall - Hip joint components
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Bangmei (Shanghai) Trading Co., Ltd., the responsible unit in China for manufacturer Biomet Orthopedics, initiated a voluntary recall of specific hip joint components on May 28, 2015. The recall involved hip joint components, specifically models 163668 and 163669. The main issue identified was an inconsistency in the main barcode (GTIN Code) information. During the conversion of Chinese labels, it was discovered that the barcode data on the product labels did not match the company’s internal label database. This discrepancy was found while products were in the Shanghai Waigaoqiao Free Trade Zone. Under the regulatory framework of the National Medical Products Administration (NMPA), Bangmei (Shanghai) Trading Co., Ltd. reported the issue, leading to a decision by headquarters to recall all problematic products in the series. All affected units were promptly returned to the original manufacturer, ensuring that no non-compliant products were distributed or sold within China.
- Company
- Biomet Orthopedics
ID · 169b1173-81f4-485e-8a04-94cd17e2c748