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Zimmer Biomet在召回期间逐步淘汰髋关节系统

Zimmer Biomet is phasing out hip system amid recall

MASSDEVICE 等信源发布 2024-09-18 01:13

可切换为仅中文


Zimmer Biomet

房间生物识别

(NYSE: ZBH)

(纽约证券交易所:ZBH)

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is voluntarily phasing out its CPT hip system amid a voluntary recall.

在自愿召回的情况下,该公司正在自愿逐步淘汰CPT髋关节系统。

The FDA today issued an alert to people with the hip system, their caregivers, and healthcare providers that warns of increased risk of thigh bone fracture after surgery (postoperative periprosthetic femoral fracture) with the use of ZB’s CPT hip system femoral stem 12/14 neck tape.

FDA今天向髋关节系统患者及其护理人员和医疗保健提供者发出警告,警告使用ZB的CPT髋关节系统股骨柄12/14颈部胶带手术后大腿骨折(术后假体周围股骨骨折)的风险增加。

Zimmer Biomet voluntarily recalled the hip system on July 2 to update use instructions due to the increased thigh bone fracture risk. It also said it planned to phase out sales of the CPT hip system by December 2024. The company informed health providers that they should consider using alternative hip systems when possible..

由于大腿骨折风险增加,Zimmer Biomet于7月2日自愿召回了髋关节系统,以更新使用说明。该公司还表示,计划在2024年12月前逐步停止CPT hip系统的销售。该公司告知健康提供者,他们应尽可能考虑使用替代髋关节系统。。

In a statement shared by a spokesperson with MassDevice, ZB said:

在MassDevice发言人分享的一份声明中,ZB表示:

“Zimmer Biomet is committed to the highest standards of patient safety, quality and integrity. The CPT Hip System has been on the market for more than 20 years, with a high survivorship rate of 96.4% at 10 years. We are now supporting customers to transition to alternative Zimmer Biomet brands as we voluntarily phase out the CPT hip system femoral stem 12/14 neck taper in 2024.”.

“Zimmer Biomet致力于患者安全性、质量和完整性的最高标准。CPT髋关节系统已上市20多年,10年生存率高达96.4%。随着我们在2024年自愿淘汰CPT髋关节系统股骨柄12/14颈锥度,我们现在正在支持客户转向替代Zimmer Biomet品牌。”。

The FDA has more details in its safety communication.

FDA在其安全通讯中有更多细节。