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 10/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source-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 upon incoming product inspection the package was found with a crease in the sealing area.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.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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