Model Number N/A |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.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 a product was mislabeled.No patient was involved.Attempts have been made, and no further information has been provided.
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Event Description
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No additional event information to report.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product and packaging identified that the outer label had incorrect information.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported event is due to a deficiency in the label change control process.This event has been investigated thru the capa process.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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