Catalog Number 950502804 |
Device Problem
Delamination (2904)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The trays have begun to peel on the insert plastic pieces.
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Manufacturer Narrative
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This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.
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Manufacturer Narrative
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Examination of the submitted devices confirmed the reported event.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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