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 visual evaluation of the returned products identified 13 boxes were returned and all 13 boxes were unopened and still with its' shrink wrap.All the boxes were then opened to retrieve each product to perform a function test.Function check was conforming and all 13 devices work as intended.Device history record was reviewed and no discrepancies were found.Review of the product determined that no failure was found as the product functions as intended.Root cause was unable to 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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