Model Number N/A |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The commingled product that was inside of the package was: part#: 905629, lot#: 625450; manufacture date: october 19, 2017; sterile expiry date: october 19, 2022; (b)(4).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.Not yet returned.
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Event Description
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It was reported that during an acl reconstruction procedure, it was discovered that the product inside was not the correct product and did not match the product id on the outer label.No adverse events have been reported as a result of the malfunction.
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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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(b)(4).Reported event was confirmed by review of the pictures of the products sent.The box and inner packaging do not have the same item & lot numbers on the labels.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to manufacturing deficiency related to production & process control.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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