Model Number N/A |
Device Problem
Device Markings/Labelling Problem (2911)
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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).
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Event Description
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It was reported the wrong ean number was printed on label.No patient involvement.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Inspection of the pictures of the complaint product determined that the incorrect gtin number is printed on the label as reported.Review of the device history record determined that the incorrect gtin number is printed on the label.No other deviations identified.Review of the complaint history determined that no further action is required as no were trends identified.The root cause of the reported issue is attributed to operator error prior to established procedures or training being implemented.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.(b)(4).
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Event Description
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It was reported that the wrong gtin number (global trade item number) was printed on the label.No patient involvement.No adverse events have been reported as a result of the malfunction.
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Search Alerts/Recalls
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