Model Number N/A |
Device Problems
Material Discolored (1170); Delivered as Unsterile Product (1421)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that during a incoming product inspection the product was found with a stain on it.There was no adverse events as a result of this malfunction as there was no patient involvement.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were update/corrected updated: upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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