Model Number 8562-11-006 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 856210009 950980 lock dist tib med rt 9h ste.856210009 950980 lock dist tib med rt 9h ste.856211006 045420 lock dist tib med lt 6h ste.Report source: foreign- japan.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02556, 0001825034-2022-02557 and 0001825034-2022-02558.
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Event Description
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It was reported during the incoming inspection at warehouse that the sterile package was not vacuumed.No adverse event has been reported as a result of the malfunction.
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Manufacturer Narrative
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Upon receipt of additional information, it has been determined that the packaging meets the standards of inspection criteria.No product failure was found as the products are within specifications.The initial report was forwarded in error and should be voided.
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Event Description
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Upon receipt of additional information, it has been determined that the packaging meets the standards of inspection criteria.No product failure was found as the products are within specifications.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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