This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10.Visual evaluation of the returned devices identified that the inner sterile pouches were broken into multiple pieces.However, evaluation of the outer pouches found no damage, and therefore sterility was not breached.The device history records were reviewed and no discrepancies were identified.As the condition of the devices was conforming when it left zimmer biomet, a definitive root cause could not be determined with the information provided.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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