Controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2019
Synthes GmbH recalls USS II Polyaxial spinal fixation system
Recall announced
Synthes GmbH initiated a recall of specified models and batches of the USS II Polyaxial spinal fixation system following an unusual trend in complaints about intraoperative abnormal sounds and cracking of locking-ring components. Johnson & Johnson (Shanghai) Medical Equipment Co. was identified as the product's agent. The notice described the recall as Class I.
Source excerpt
此次召回的级别为一级，涉及德国、瑞士、中国、日本、澳大利亚等国家和地区
由于涉及产品可能存在术中异响及锁定环部件开裂问题，生产商Synthes GmbH对多轴向椎弓根固定系统USS II Polyaxial(注册证编号：国械注进20173462011)主动召回。
2010
Norian guilty pleas and penalties
Synthes and Norian pleaded guilty to criminal allegations involving the shipment of adulterated and misbranded products and interference with FDA functions. Norian agreed to a $23 million fine and divestiture, while four former executives later received prison sentences ranging from five to nine months.
2009
Norian XR regulatory and clinical-trial controversy
US prosecutors alleged that Synthes and Norian promoted Norian XR for spinal uses not authorized by the FDA, conducted unauthorized clinical investigations, failed to report adverse events properly, and made false statements during an FDA inspection. The case involved allegations concerning deaths during procedures and safety concerns related to the material's interaction with blood.