Health Canada — Medical Devices · Canada · 2017-05-02 · Type II
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Reported risk: Stryker received a complaint regarding a Standard Lag Screw Omega 110mm length. It was reported that the lag screw was not completely cannulated and the guide wire could not go through the cannula of the screw. No harm reported. The investigation revealed that the obstruction is related to a metal burr in the cannula of the screw which was not removed during manufacturing. The non-conformance is limited to 2 batches.
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