FDA-Device2021-06-23Class II

Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.

Corin Ltd
Hazard

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.

Sold states
US Nationwide distribution in the state of TX.
Affected count
1 unit
Manufactured in
Unit 1-57-8, Corinium Centre, Cirencester, United Kingdom
Products
Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1851-2021

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