This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h3, h6, h10 lot identification is necessary for review of device history records, and was not provided.No product was returned; visual and dimensional evaluations could not be performed.The root cause was determined to be a design issue.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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