Controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2020
Smith & Nephew announces recalls of medical devices in China
Recall announced
Smith & Nephew entities announced recalls in China of knee and hip surgery instruments and endoscopic hand instruments. The recalls were attributed to labeling or packaging errors. A separate recall of hip instruments cited a design issue that could potentially cause a guide to break.
Company response
Recall — Smith & Nephew, Inc.
生产商Smith & Nephew,Inc.美国施乐辉有限公司对膝关节手术器械(备案凭证编码:国械备20151696号)、髋关节手术器械(备案凭证编码:国械备20151787号)主动召回。
Source excerpt
8月18日,国家药品监督管理局网站发布了Smith & Nephew,Inc.美国施乐辉有限公司对膝关节手术器械、髋关节手术器械主动召回的公告。
日前,施乐辉医用产品国际贸易(上海)有限公司报告,由于涉及产品设计问题,导致与配套使用工具的连接处缝隙较小,可能存在导板断裂的问题。
2017
Mölnlycke litigation over ALLEVYN LIFE claims
Mölnlycke alleged that Smith+Nephew’s advertising and promotional materials made misleading, unsubstantiated or improperly comparative claims about ALLEVYN LIFE dressings and pressure-ulcer prevention. The supplied material describes allegations in a lawsuit, not a confirmed regulatory or judicial finding.