Cmp-(b)(4).Updated: b4, b5, g3, h1, h2, h3, h6, h10 visual evaluation of the returned product found the suture was not cycled.No packaging was returned.The device was previously opened, therefore, no statements can be made regarding the reported event.This complaint cannot be confirmed.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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