贵州众基义齿主动召回多批定制式正畸活动矫治器Issuing time:2025-10-13 12:33
好的牙·讯|近日,贵州省药品监督管理局发布公示公告披露,贵州众基义齿科技有限公司(以下简称“众基义齿”)报告,因代型材料超适用范围使用,该公司主动召回其生产的定制式正畸活动矫治器(注册号:黔械注准20232170038),召回级别为三级。
医疗器械召回事件报告表显示,此次召回的产品为定制式正畸活动矫治器(压膜保持器),适用于口腔正畸,涉及250714001、250714166、250714174等多个批次,销售数量为73个。 众基义齿在报告表中指出,召回原因是代型材料超适用范围使用,可能存在潜在的质量隐患,会对召回产品进行报废处理。
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