The product was returned for evaluation and the complaint was confirmed.Per engineer's investigation, "the label has a 4 that appears as a 1".Internal actions were taken to address this issue.Review of the dhr found units were released for distribution with no deviation or anomaly.Review of complaint history found no additional issues or trends.The suspected root cause of this label misprint is a small wrinkle in the printing ribbon making this an incident isolated to this label.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation."product is not labeled, or is mislabeled/incorrect information on the label." following review, no new risks were identified.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.Zimmer biomet complaint (b)(4).
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