Recall Z-0214-2024— Corin Ltd

Name: FDA recall Z-0214-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-13

Class II · Ongoing

Class II FDA medical device recall by Corin Ltd, initiated 2023-10-13. It names one FDA 510(k) clearance: K113060. Product: Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty. Reason: Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa..

Recalling firm: Corin Ltd
Classification: Class II
Status: Ongoing
Initiated: 2023-10-13
Firm location: Cirencester, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K113060 — UNITY TOATAL KNEE SYSTEMCorin USA·cleared 2012-09-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty

Reason for recall

Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

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