Model Number N/A |
Device Problems
Material Discolored (1170); Delivered as Unsterile Product (1421)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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.
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Event Description
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It is reported that during incoming product inspection the product was found with a stain on the product.There were no adverse events reported as there was no patient involvement.
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Manufacturer Narrative
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Upon receipt of additional information, it has been determined that this device was conforming to specifications as the cosmetic issue does not impact the form, fit, function or sterility of the product.The initial report was forwarded in error and should be voided.
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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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Search Alerts/Recalls
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