Recall Z-2606-2021— Corin Ltd

Name: FDA recall Z-2606-2021
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: K111481. Product: Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, 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

K111481 — CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERSCorin USA·cleared 2012-02-06

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 Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, 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.