Health Canada — Medical Devices · Canada · 2017-02-27 · Type III
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Reported risk: Smith & Nephew is initiating a voluntary field corrective action/recall of various batches of the full radius blade, 3.5mm due to a manufacturing error. The product was manufactured with a black ULTEM sluff chamber instead of a blue polycarbonate one. Smith & Nephew Considers that the use or exposure to the product is unlikely to cause adverse health consequences. The colour of the sluff chamber is irrelevant to the clinical use and the material has no impact on the device performance. The device will perform as intended.
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