(b)(4).Reported device is involved in initiated recall, however correction/removal reporting number has not been received.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product determined that the product is etched with the lot number that matches the outer device packaging/labeling for a comprehensive micro stem 17mm.However, dimensional analysis of the returned product determined that is consistent with comprehensive mini stem 13mm.The root cause of the reported issue is attributed to a manufacturing deficiency as it is likely that the products were comingled during cleaning prior to laser etch.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.Multiple mdr reports have been reported for this event, please see associated report: 0001825034 - 2017 - 11109.
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