Model Number N/A |
Device Problems
Delivered as Unsterile Product (1421); Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 mdr will be submitted.
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Event Description
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It is reported that during incoming product inspection they found a package with air bubbles in the sterile seal.
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Event Description
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No additional information received.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was not confirmed; the seal of the packaging is acceptable per criteria.Dhr was reviewed and no discrepancies were found.The device analysis indicated that the device met specification.After product evaluation this is no longer considered a reportable event as there is no product failure.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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