Model Number N/A |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.(b)(4).The device was not returned, however, other samples and manufacture records were reviewed and the labeling discrepancy of the label containing 'avl' when it is a standard component was confirmed; the actual device was manufactured to specification and would still be compatible with standard or avl oss components.Corrective action has been initiated to address the reported issue.
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Event Description
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It was reported that the label of the modular proximal tibia has a discrepancy in the description.
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Manufacturer Narrative
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This complaint is recorded with zimmer biomet under (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Review of the dhr found a related anomaly:and the labeling discrepancy of the label containing 'avl' when it is a standard component was confirmed; the actual device was manufactured to specification and would still be compatible with standard or avl oss components.Investigation results concluded that the reported event was due to an error in the global label process.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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It was reported that he label of the modular proximal tibia has a discrepancy in the description.Additional information received noted the device was not needed and the procedure was completed without delay.
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Search Alerts/Recalls
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