Model Number N/A |
Device Problem
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).(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.Expected, not yet received.
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Event Description
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It was reported during incoming inspection at the warehouse, that it was discovered there was a crease in the sealing area.There was no patient involvement.
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Event Description
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No additional information received.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.Complaint sample was evaluated and the reported event was not confirmed.Evaluation of the returned products found the seal to be within specifications.Since the seal was acceptable and there would be no risk to the sterility of the device, re-evaluation of this product to no longer be reportable for this event; the event is being reported on 0001822565-2018-06344.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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Search Alerts/Recalls
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