(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.No photos were provided or product returned.No evaluation can be performed.Review of the device history records identified no related deviations or anomalies during manufacturing.Medical records were not provided.These products were likely conforming when they left zimmer biomet control.However, the products have been redistributed, and therefore, the root cause cannot be determined.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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