Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the product was received and the sterile package was not vacuum sealed.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Report source: foreign: japan.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02412.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Evaluation of the returned product found the packaging meets the standards of inspection criteria.No product failure was found as the products are within specifications.No further investigation or action is required after review.As no product failure was found, this complaint will be deemed not reportable.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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