Z-2604-2021 Class II Terminated
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
- 6 units
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.
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 321.035 - Lot number 481070 was delivered 7/23/2021 and 7/26/2021; and Model 321.050 - Lot number 478892 was delivered 7/23/2021.