Catalog Number 180551 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Event country: foreign: (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 report will be submitted.Product not returned.
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Event Description
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It was reported that the sterile packaging was found to be opened.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual inspection of the returned product found the tyvek pouch was not heat sealed during the manufacturing process.Sterility has been compromised.Review of the device history records identified no related deviations or anomalies during manufacturing.These products were likely non-conforming when they left zimmer biomet control.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.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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Search Alerts/Recalls
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