Recall Z-2607-2021— Corin Ltd

Class II · Terminated

Class II FDA medical device recall by Corin Ltd, initiated 2021-07-28, terminated 2024-06-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component 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

Product description

Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component 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.