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PubMed

Recall trends of FDA-cleared shoulder and elbow devices.

PMID: 41548593 ·

J, o, h, n, l, e, v, i, , S, , L, a, z, a, r, o, ;, , D, e, n, i, s, e, , B, i, o, n, ;, , L, u, k, e, , S, , A, u, s, t, i, n

RevistaJournal of shoulder and elbow surgery
Ano
PMID41548593

Resumo

The requirements for medical device approvals are based on the classification and the associated risks. Based on the type of approval, there can be a higher risk of recall for orthopedic medical devices. The purpose of this study is to analyze the risk of recall for shoulder/elbow devices. A retrospective review was conducted of publicly available U.S. Food and Drug Administration databases to identify cleared for market and recalled shoulder and elbow devices. Nonorthopedic and unrelated device

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