Model Number N/A |
Device Problem
Shipping Damage or Problem (1570)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported by the distributor the product arrived damaged with sterility barrier potentially compromised.There was no patient involvement.
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Event Description
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No further information available at this time.
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Manufacturer Narrative
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It was identified in investigation this device did not cause or contribute to a serious injury or reportable malfunction.Visual inspection of the returned product identified that the outer box is crushed.The sterile cavity was deformed but the sterile barrier was still intact.The sterility of the product was not compromised.Please consider this submission void.
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Search Alerts/Recalls
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