Catalog Number 829029170 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Udi: (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.Product not returned.
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Event Description
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It was reported that the sterile packaging was received damaged.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product identified that the seal area had a void.The root cause was determined to be transit damage.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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