Z-2606-2021 Class II Terminated

Recalled by Corin Ltd — Cirencester, N/A

Recall Details

Product Type
Devices
Report Date
October 6, 2021
Initiation Date
July 28, 2021
Termination Date
June 12, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units

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.

Distribution Pattern

US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.

Code Information

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 322.04.640 - Lot number 479381 was delivered 7/22/2021 and 7/23/2021; Model 322.04.936 - Lot number 479878 was delivered 7/22/2021 and 7/26/2021.