Catalog Number 131212318 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/28/2018 |
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 receiving inspection, a blue stain was found in the sterile package.
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Manufacturer Narrative
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Visual inspection of the returned product confirmed the reported event as a blue stain inside the sterile sleeve was identified.Dhr was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to an operator error during the manufacturing 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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Event Description
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No additional information received.
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Search Alerts/Recalls
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