Catalog Number 5070001000 |
Device Problems
Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/15/2015 |
Event Type
Other
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Event Description
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It is reported that at hospital, upon receipt of original packed instrument, it was detected that the laser marking of the device is illegible.
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Manufacturer Narrative
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The mfr did not receive devices for review.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).
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Manufacturer Narrative
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The manufacturer did not receive devices or other source documents for review.Compatibility check: the compatibility check was performed and showed that the product combination was approved.Event description: laser marking is not legible.As the instrument has not been returned, a product analysis could not be performed.Therefore, the complaint could not be confirmed for this product.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).
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Search Alerts/Recalls
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