Catalog Number 3910-500-322 |
Device Problems
Contamination (1120); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that there was foreign material inside the sterile packaging.
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Manufacturer Narrative
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Alleged failure: lint was noticed in the sterile package of the iconix anchor.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be a manufacturing issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Event Description
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It was reported that there was foreign material inside the sterile packaging.
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Search Alerts/Recalls
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