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Lot Number 2213789-70000 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/03/2022 |
Event Type
malfunction
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Event Description
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Patient underwent left high tibial osteotomy, abrasion chondroplasty medial tibia and revision of acl reconstruction utilizing allograft material supplied by vendor.Vendor contacted surgeon 3 months later to report that allograft product used during this surgery may have failed several quality assurance tests to rule out presence of infectious diseases.Vendor reported low likelihood of disease transmission.Patient was notified and contacted vendor himself (patient is a physician) for further information.
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Search Alerts/Recalls
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