Recall Z-1850-2021— Corin Ltd

Name: FDA recall Z-1850-2021
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 TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. 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 TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. 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.