Recall Z-2604-2021— Corin Ltd

Name: FDA recall Z-2604-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-28

Class II · Terminated

Class II FDA medical device recall by Corin Ltd, initiated 2021-07-28, terminated 2024-06-12. It names one FDA 510(k) clearance: K093472. Product: Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are components of the Trinity Acetabular System.. Reason: The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices..

Recalling firm: Corin Ltd
Classification: Class II
Status: Terminated
Initiated: 2021-07-28
Terminated: 2024-06-12
Firm location: Cirencester, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K093472 — TRINITY ACETABULAR SYSTEMCorin USA·cleared 2010-11-23

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

Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are components of the Trinity Acetabular System.

Reason for recall

The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

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