Health Canada — Medical Devices · Canada · 2018-09-07 · Type II
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Reported risk: Stryker GMBH identified a non-conformance with a supplier. The manufacturer has determined that products have left the factory where the press fit connection of the angular sleeve and pin of the u-joint and click lock did not meet specification. A dimensional discrepancy of the bore hole of the angular sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.
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