Recall Z-0273-2023— Corin Ltd

Name: FDA recall Z-0273-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-31

Class II · Terminated

Class II FDA medical device recall by Corin Ltd, initiated 2022-10-31, terminated 2024-01-12. It names one FDA 510(k) clearance: K113060. Product: Unity Total Knee System. Used for knee prosthesis in total knee replacement. Reason: The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging..

Recalling firm: Corin Ltd
Classification: Class II
Status: Terminated
Initiated: 2022-10-31
Terminated: 2024-01-12
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. Used for knee prosthesis in total knee replacement

Reason for recall

The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

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