Anthem 71422945Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556655887), received between Aug 12, 2024 and Aug 12, 2024 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K170648, K230653); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER RIGHT TKA SURGERY THAT WAS PERFORMED ON (B)(6) 2023, THE PATIENT PRESENTED FEMORAL RADIOLUCENCIES ON (B)(6) 2024. IN ADDITION, THE CLINICAL STUDY IDENTIFIED OSTEOLYSIS ON THE FEMORAL COMPONENT. IT IS UNKNOWN HOW THIS EVENT WAS TREATED. CURRENT OUTCOME IS UNRESOLVED.

  Patient problems: Osteolysis; Radiolucent Lines

  MAUDE report 19968001 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170648, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint