This user facility is outside of the united states.The necessary manufacturing history was not provided for review.Current information is insufficient to permit a conclusion as to the cause of the event.This device is not manufactured by zimmer biomet in the united states; however, we are filing this report as zimmer biomet manufactures a similar device in the united states under 510k number k023357.This report is number 2 of 2 mdrs filed for the same patient (reference 3002806535-2016-00634 / 00635).Product requested, not yet returned.
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