Medical device recalls Moderate risk

Corin Ltd recalls Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.

Recall date
May 6, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1850-2021
FDA classification
Class II
Brand / firm
Corin Ltd
Sold / distributed
US Nationwide distribution in the state of TX.

Why it was recalled

Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.

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