蓝鲸新闻4月2日讯,国家药监局网站4月1日发布通告,美国施乐辉有限公司(Smith & Nephew, Inc.)因部分交锁髓内钉系统(TriGen IM Nail System,国械注进20153134228)存在生产失误,对其实施二级主动召回。通报指出,问题主要涉及个别批次产品可能存在的制造缺陷,但经评估,本次召回行动不影响中国市场在用产品的安全性与有效性。施乐辉医用产品国际贸易(上海)有限公司已按要求提交召回事件报告表,并配合监管部门开展后续核查。消费者如发现相关产品异常,可及时向使用单位或监管部门反馈。
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