This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d9, g3, g6, h2, h3, h6, h10 visual evaluation of the returned product identified that there is hair-like debris inside the sterile packaging blister.The complaint has been confirmed by visual evaluation.Device history record was reviewed and no discrepancies relevant to the reported event were found.The product was likely non-conforming when it left zimmer biomet control.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.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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