Recall Z-1851-2021— Corin Ltd

Name: FDA recall Z-1851-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-06

Class II · Terminated

Class II FDA medical device recall by Corin Ltd, initiated 2021-05-06, terminated 2023-07-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.. Reason: 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..

Recalling firm: Corin Ltd
Classification: Class II
Status: Terminated
Initiated: 2021-05-06
Terminated: 2023-07-05
Firm location: Cirencester, United Kingdom

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.