1 Death, 11 Injuries Lead To Class I Recall For Stryker’s Trevo Retriever
The US FDA gave its highest risk classification to a recall by Stryker of a medical device that’s used on stroke patients.
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The recall of the kit, which is part of the HeartWare HVAD System, was affixed with the US agency’s highest risk classification on 1 March.
It’s yet another internal deadline missed by the US agency in publishing a draft of its overhauled Quality System Regulation, which is being harmonized with international quality systems standard ISO 13485.
Device Week, 26 February 2021 – Inside Integrum’s Journey To Secure FDA Approval For Novel Prosthetic
On this week’s podcast we talk about some hurdles that Swedish start-up Integrum leapt when applying for premarket approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.