Catalog Number 856135028 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).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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During receiving inspection debris was found in the sterile packaging.
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Event Description
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No additional information received.
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Manufacturer Narrative
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Visual inspection of the returned product confirmed the reported event as a piece of unknown debris was identified the sealed sterile packaging.Dhr was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to operator error during the manufacturing process; actions have been initiated to address this error.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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