(b)(4).Foreign: country: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Lot #64063155 exhibited a damaged outer tyvek lid so the sterility is compromised.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the parts when they left zimmer biomet control is considered conforming based on the evaluation of the returned products, the dhrs review, and the potential transit age of the devices (20 months).The root cause of the reported issue is attributed to transit damage.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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