FDA recall Z-2604-2021

Corin Ltd · Class II · device

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 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

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

Key facts

Status
Terminated
Initiation date
2021-07-28
Report date
2021-10-06
Termination date
2024-06-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cirencester, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2604-2021